VIDEO: Dr. William Gradishar says tools to define patients for targeted therapy are on the horizon

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VIDEO: Dr. William Gradishar says tools to define patients for targeted therapy are on the horizon

SAN ANTONIO – Clinicians can expect tools to appear in the clinic in the very near future that will help define who will benefit from targeted therapy and who can get by with less therapy, Dr. William J. Gradishar asserted at the San Antonio Breast Cancer Symposium.

In particular, Dr. Gradishar cited BOLERO-2 and BELLE-2 results as evidence that evaluating the tumors of patients can lead to identifying those who will obtain benefit from targeted agents.

In a video interview, Dr. Gradishar also outlined where things stand on extended therapy for HER2-positive patients, and whether the use of osteoclast inhibitors is a new standard of care.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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SAN ANTONIO – Clinicians can expect tools to appear in the clinic in the very near future that will help define who will benefit from targeted therapy and who can get by with less therapy, Dr. William J. Gradishar asserted at the San Antonio Breast Cancer Symposium.

In particular, Dr. Gradishar cited BOLERO-2 and BELLE-2 results as evidence that evaluating the tumors of patients can lead to identifying those who will obtain benefit from targeted agents.

In a video interview, Dr. Gradishar also outlined where things stand on extended therapy for HER2-positive patients, and whether the use of osteoclast inhibitors is a new standard of care.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

SAN ANTONIO – Clinicians can expect tools to appear in the clinic in the very near future that will help define who will benefit from targeted therapy and who can get by with less therapy, Dr. William J. Gradishar asserted at the San Antonio Breast Cancer Symposium.

In particular, Dr. Gradishar cited BOLERO-2 and BELLE-2 results as evidence that evaluating the tumors of patients can lead to identifying those who will obtain benefit from targeted agents.

In a video interview, Dr. Gradishar also outlined where things stand on extended therapy for HER2-positive patients, and whether the use of osteoclast inhibitors is a new standard of care.

Dr. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

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VIDEO: Cleveland Clinic experts provide SABCS take-home messages

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SAN ANTONIO –The San Antonio Breast Cancer Symposium had a lot to offer clinicians. Cleveland Clinic breast cancer experts Dr. Jame Abraham, Dr. Holly Pederson, and Dr. Alberto Montero outline take-home messages from research presented at the San Antonio Breast Cancer Symposium. The panel agreed that some findings were practice-changing – particularly results showing adjuvant denosumab not only reduces fracture risk for women but also improves breast cancer outcomes – while findings for other treatments, including immunotherapy for breast cancer, have a long way to go before arriving in the clinic.

Dr. Pederson highlighted presentations on prevention, including findings linking aspirin with lower breast density. She also said presentations confirmed for her that gene panels are here to stay in helping identify and manage women at high risk of breast cancer.

The panelists also discussed the clinical relevance of studies on neoadjuvant carboplatin and on using capecitabine for cleanup of residual disease after neoadjuvant therapy.

The three panelists had no financial disclosures related to these studies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

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SAN ANTONIO –The San Antonio Breast Cancer Symposium had a lot to offer clinicians. Cleveland Clinic breast cancer experts Dr. Jame Abraham, Dr. Holly Pederson, and Dr. Alberto Montero outline take-home messages from research presented at the San Antonio Breast Cancer Symposium. The panel agreed that some findings were practice-changing – particularly results showing adjuvant denosumab not only reduces fracture risk for women but also improves breast cancer outcomes – while findings for other treatments, including immunotherapy for breast cancer, have a long way to go before arriving in the clinic.

Dr. Pederson highlighted presentations on prevention, including findings linking aspirin with lower breast density. She also said presentations confirmed for her that gene panels are here to stay in helping identify and manage women at high risk of breast cancer.

The panelists also discussed the clinical relevance of studies on neoadjuvant carboplatin and on using capecitabine for cleanup of residual disease after neoadjuvant therapy.

The three panelists had no financial disclosures related to these studies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

SAN ANTONIO –The San Antonio Breast Cancer Symposium had a lot to offer clinicians. Cleveland Clinic breast cancer experts Dr. Jame Abraham, Dr. Holly Pederson, and Dr. Alberto Montero outline take-home messages from research presented at the San Antonio Breast Cancer Symposium. The panel agreed that some findings were practice-changing – particularly results showing adjuvant denosumab not only reduces fracture risk for women but also improves breast cancer outcomes – while findings for other treatments, including immunotherapy for breast cancer, have a long way to go before arriving in the clinic.

Dr. Pederson highlighted presentations on prevention, including findings linking aspirin with lower breast density. She also said presentations confirmed for her that gene panels are here to stay in helping identify and manage women at high risk of breast cancer.

The panelists also discussed the clinical relevance of studies on neoadjuvant carboplatin and on using capecitabine for cleanup of residual disease after neoadjuvant therapy.

The three panelists had no financial disclosures related to these studies.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

[email protected]

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EXPERT ANALYSIS FROM SABCS 2015

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What’s anticipated at SABCS 2015?

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FROM SABCS 2015 – A survey of Oncology Practice board members, including Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology, Northwestern University, Chicago, and medical oncologists at the Cleveland Clinic who will be attending the San Antonio Breast Cancer Symposium, revealed several anticipated studies from this year’s symposium, set to begin on Wednesday, Dec. 9. Titles, and links to abstracts if available, are listed below:

• S2-02 The Impact of Adjuvant Denosumab on Disease-Free Survival: Results from 3,425 Postmenopausal Patients of the ABCSG-18 Trial.

• S2-05 Event-free and overall survival following neoadjuvant weekly paclitaxel and dose-dense AC +/-carboplatin and/or bevacizumab in triple-negative breast cancer: Outcomes from CALGB 40603 (Alliance).

• S5-05 Trastuzumab emtansine improves overall survival versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase III TH3RESA study.

S1-05 Prophylactic beta blockade preserves left ventricular ejection fraction in HER2-overexpressing breast cancer patients receiving trastuzumab: Primary results of the MANTICORE randomized controlled trial.

• S1-07 A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04).

S4-01 Identification of early versus late drivers of breast tumors and metastasis.

• S5-07 Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1–positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028.

S1-09 A comparison of the diagnostic performance of 2D synthetic mammography versus digital breast tomosynthesis in 2,500 patients.

• S6-01 PIK3CA status in circulating tumor DNA (ctDNA) predicts efficacy of buparlisib (BUP) plus fulvestrant (FULV) in postmenopausal women with endocrine-resistant HR+/HER2– advanced breast cancer (BC): First results from the randomized, phase III BELLE-2 trial.

• S5-04 Ten-year follow-up of the BCIRG-006 trial comparing doxorubicin plus cyclophosphamide followed by docetaxel (AC®T) with doxorubicin plus cyclophosphamide followed by docetaxel and trastuzumab (AC®TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2+ early breast cancer patients.

• S3-05 Higher 10-year overall survival after breast conserving therapy compared to mastectomy in early stage breast cancer: a population-based study with 37,207 patients.

S1-04 Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase Ib JAVELIN solid tumor trial.

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FROM SABCS 2015 – A survey of Oncology Practice board members, including Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology, Northwestern University, Chicago, and medical oncologists at the Cleveland Clinic who will be attending the San Antonio Breast Cancer Symposium, revealed several anticipated studies from this year’s symposium, set to begin on Wednesday, Dec. 9. Titles, and links to abstracts if available, are listed below:

• S2-02 The Impact of Adjuvant Denosumab on Disease-Free Survival: Results from 3,425 Postmenopausal Patients of the ABCSG-18 Trial.

• S2-05 Event-free and overall survival following neoadjuvant weekly paclitaxel and dose-dense AC +/-carboplatin and/or bevacizumab in triple-negative breast cancer: Outcomes from CALGB 40603 (Alliance).

• S5-05 Trastuzumab emtansine improves overall survival versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase III TH3RESA study.

S1-05 Prophylactic beta blockade preserves left ventricular ejection fraction in HER2-overexpressing breast cancer patients receiving trastuzumab: Primary results of the MANTICORE randomized controlled trial.

• S1-07 A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04).

S4-01 Identification of early versus late drivers of breast tumors and metastasis.

• S5-07 Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1–positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028.

S1-09 A comparison of the diagnostic performance of 2D synthetic mammography versus digital breast tomosynthesis in 2,500 patients.

• S6-01 PIK3CA status in circulating tumor DNA (ctDNA) predicts efficacy of buparlisib (BUP) plus fulvestrant (FULV) in postmenopausal women with endocrine-resistant HR+/HER2– advanced breast cancer (BC): First results from the randomized, phase III BELLE-2 trial.

• S5-04 Ten-year follow-up of the BCIRG-006 trial comparing doxorubicin plus cyclophosphamide followed by docetaxel (AC®T) with doxorubicin plus cyclophosphamide followed by docetaxel and trastuzumab (AC®TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2+ early breast cancer patients.

• S3-05 Higher 10-year overall survival after breast conserving therapy compared to mastectomy in early stage breast cancer: a population-based study with 37,207 patients.

S1-04 Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase Ib JAVELIN solid tumor trial.

[email protected]

FROM SABCS 2015 – A survey of Oncology Practice board members, including Dr. William J. Gradishar, Betsy Bramsen Professor of Breast Oncology, Northwestern University, Chicago, and medical oncologists at the Cleveland Clinic who will be attending the San Antonio Breast Cancer Symposium, revealed several anticipated studies from this year’s symposium, set to begin on Wednesday, Dec. 9. Titles, and links to abstracts if available, are listed below:

• S2-02 The Impact of Adjuvant Denosumab on Disease-Free Survival: Results from 3,425 Postmenopausal Patients of the ABCSG-18 Trial.

• S2-05 Event-free and overall survival following neoadjuvant weekly paclitaxel and dose-dense AC +/-carboplatin and/or bevacizumab in triple-negative breast cancer: Outcomes from CALGB 40603 (Alliance).

• S5-05 Trastuzumab emtansine improves overall survival versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase III TH3RESA study.

S1-05 Prophylactic beta blockade preserves left ventricular ejection fraction in HER2-overexpressing breast cancer patients receiving trastuzumab: Primary results of the MANTICORE randomized controlled trial.

• S1-07 A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04).

S4-01 Identification of early versus late drivers of breast tumors and metastasis.

• S5-07 Preliminary efficacy and safety of pembrolizumab (MK-3475) in patients with PD-L1–positive, estrogen receptor-positive (ER+)/HER2-negative advanced breast cancer enrolled in KEYNOTE-028.

S1-09 A comparison of the diagnostic performance of 2D synthetic mammography versus digital breast tomosynthesis in 2,500 patients.

• S6-01 PIK3CA status in circulating tumor DNA (ctDNA) predicts efficacy of buparlisib (BUP) plus fulvestrant (FULV) in postmenopausal women with endocrine-resistant HR+/HER2– advanced breast cancer (BC): First results from the randomized, phase III BELLE-2 trial.

• S5-04 Ten-year follow-up of the BCIRG-006 trial comparing doxorubicin plus cyclophosphamide followed by docetaxel (AC®T) with doxorubicin plus cyclophosphamide followed by docetaxel and trastuzumab (AC®TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2+ early breast cancer patients.

• S3-05 Higher 10-year overall survival after breast conserving therapy compared to mastectomy in early stage breast cancer: a population-based study with 37,207 patients.

S1-04 Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase Ib JAVELIN solid tumor trial.

[email protected]

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FDA approves nivolumab for metastatic renal cell carcinoma

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FDA approves nivolumab for metastatic renal cell carcinoma

The Food and Drug Administration has approved nivolumab for the treatment of patients with metastatic renal cell carcinoma who have previously received antiangiogenic therapy, expanding on approval of the PD-1 inhibitor for melanoma and non–small cell lung cancer.

The approval was based on improvement in overall survival in CheckMate 025, an open-label, randomized study involving 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an antiangiogenic agent. Patients were treated with nivolumab or everolimus. Median overall survival was 25 months with nivolumab and 19.6 months with everolimus, representing a 27% reduction in the risk of all-cause death (hazard ratio for death, 0.73; P = .0018).

This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors, according to a Nov. 23 statement issued by the FDA.

The most common side effects of nivolumab treatment were fatigue, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, and arthralgia.

The FDA cautioned that nivolumab also has the potential to cause serious immune-mediated side effects.

The FDA granted the nivolumab application a breakthrough therapy designation, fast track designation, and priority review status. Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer, the FDA said.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb.

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The Food and Drug Administration has approved nivolumab for the treatment of patients with metastatic renal cell carcinoma who have previously received antiangiogenic therapy, expanding on approval of the PD-1 inhibitor for melanoma and non–small cell lung cancer.

The approval was based on improvement in overall survival in CheckMate 025, an open-label, randomized study involving 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an antiangiogenic agent. Patients were treated with nivolumab or everolimus. Median overall survival was 25 months with nivolumab and 19.6 months with everolimus, representing a 27% reduction in the risk of all-cause death (hazard ratio for death, 0.73; P = .0018).

This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors, according to a Nov. 23 statement issued by the FDA.

The most common side effects of nivolumab treatment were fatigue, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, and arthralgia.

The FDA cautioned that nivolumab also has the potential to cause serious immune-mediated side effects.

The FDA granted the nivolumab application a breakthrough therapy designation, fast track designation, and priority review status. Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer, the FDA said.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb.

The Food and Drug Administration has approved nivolumab for the treatment of patients with metastatic renal cell carcinoma who have previously received antiangiogenic therapy, expanding on approval of the PD-1 inhibitor for melanoma and non–small cell lung cancer.

The approval was based on improvement in overall survival in CheckMate 025, an open-label, randomized study involving 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an antiangiogenic agent. Patients were treated with nivolumab or everolimus. Median overall survival was 25 months with nivolumab and 19.6 months with everolimus, representing a 27% reduction in the risk of all-cause death (hazard ratio for death, 0.73; P = .0018).

This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors, according to a Nov. 23 statement issued by the FDA.

The most common side effects of nivolumab treatment were fatigue, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, and arthralgia.

The FDA cautioned that nivolumab also has the potential to cause serious immune-mediated side effects.

The FDA granted the nivolumab application a breakthrough therapy designation, fast track designation, and priority review status. Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer, the FDA said.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb.

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FDA approves daratumumab for multiple myeloma

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FDA approves daratumumab for multiple myeloma

The Food and Drug Administration has granted accelerated approval to daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, the agency announced Nov. 16. Daratumumab is the first monoclonal antibody approved for the treatment of multiple myeloma.

Approval was based on an objective response rate of 29% (95% confidence interval, 21%-39%) with a median response duration of 7.4 months in 106 patients with relapsed or refractory multiple myeloma treated with daratumumab monotherapy in a multicenter, open-label study.

Safety was evaluated in 156 patients in two open-label studies. The most frequently reported adverse reactions were infusion reactions, fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection. The most common laboratory abnormalities were lymphopenia, neutropenia, anemia, and thrombocytopenia, the FDA said.

Daratumumab, marketed as Darzalex, interferes with blood bank cross-matching, specifically with Indirect Antiglobulin Tests, and the FDA recommends that, if a transfusion is necessary, to inform the blood bank that a patient has received daratumumab.

As a condition of accelerated approval, the FDA is requiring manufacturer Janssen Biotech to follow-up with a randomized trial establishing the superiority of daratumumab over standard therapy. The company has several ongoing multicenter, randomized trials in patients with multiple myeloma with a primary endpoint of progression-free survival.

The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.

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The Food and Drug Administration has granted accelerated approval to daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, the agency announced Nov. 16. Daratumumab is the first monoclonal antibody approved for the treatment of multiple myeloma.

Approval was based on an objective response rate of 29% (95% confidence interval, 21%-39%) with a median response duration of 7.4 months in 106 patients with relapsed or refractory multiple myeloma treated with daratumumab monotherapy in a multicenter, open-label study.

Safety was evaluated in 156 patients in two open-label studies. The most frequently reported adverse reactions were infusion reactions, fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection. The most common laboratory abnormalities were lymphopenia, neutropenia, anemia, and thrombocytopenia, the FDA said.

Daratumumab, marketed as Darzalex, interferes with blood bank cross-matching, specifically with Indirect Antiglobulin Tests, and the FDA recommends that, if a transfusion is necessary, to inform the blood bank that a patient has received daratumumab.

As a condition of accelerated approval, the FDA is requiring manufacturer Janssen Biotech to follow-up with a randomized trial establishing the superiority of daratumumab over standard therapy. The company has several ongoing multicenter, randomized trials in patients with multiple myeloma with a primary endpoint of progression-free survival.

The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.

[email protected]

The Food and Drug Administration has granted accelerated approval to daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, the agency announced Nov. 16. Daratumumab is the first monoclonal antibody approved for the treatment of multiple myeloma.

Approval was based on an objective response rate of 29% (95% confidence interval, 21%-39%) with a median response duration of 7.4 months in 106 patients with relapsed or refractory multiple myeloma treated with daratumumab monotherapy in a multicenter, open-label study.

Safety was evaluated in 156 patients in two open-label studies. The most frequently reported adverse reactions were infusion reactions, fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection. The most common laboratory abnormalities were lymphopenia, neutropenia, anemia, and thrombocytopenia, the FDA said.

Daratumumab, marketed as Darzalex, interferes with blood bank cross-matching, specifically with Indirect Antiglobulin Tests, and the FDA recommends that, if a transfusion is necessary, to inform the blood bank that a patient has received daratumumab.

As a condition of accelerated approval, the FDA is requiring manufacturer Janssen Biotech to follow-up with a randomized trial establishing the superiority of daratumumab over standard therapy. The company has several ongoing multicenter, randomized trials in patients with multiple myeloma with a primary endpoint of progression-free survival.

The recommended dose and schedule for daratumumab is 16 mg/kg once every week for 8 weeks, then once every 2 weeks for 16 weeks, then once every 4 weeks until disease progression.

[email protected]

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FDA approves trabectedin for some advanced soft tissue sarcomas

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FDA approves trabectedin for some advanced soft tissue sarcomas

The Food and Drug Administration has approved trabectedin for the treatment of advanced or unresectable liposarcomas and leiomyosarcomas that have been previously treated with anthracycline-based regimens.

Approval is based on improvements in progression-free survival in a trial of 518 participants with metastatic or recurrent leiomyosarcoma or liposarcoma, randomly assigned to receive either trabectedin (345 patients) or dacarbazine (173 patients). Median progression-free survival was 4.2 months for those in the trabectedin arm, compared with 1.5 months for those in the dacarbazine arm, according to an Oct. 23 statement issued by the FDA.

The most common side effects for those in the trabectedin arm were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.

The drug label carries a warning of the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Women should be advised of potential risks to a developing fetus, and those who are breastfeeding should not take trabectedin, the FDA said.

Trabectedin, an alkylating drug, is marketed as Yondelis by Janssen Products of Raritan, N.J.

The label is available on the FDA website at drugsatfda.

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The Food and Drug Administration has approved trabectedin for the treatment of advanced or unresectable liposarcomas and leiomyosarcomas that have been previously treated with anthracycline-based regimens.

Approval is based on improvements in progression-free survival in a trial of 518 participants with metastatic or recurrent leiomyosarcoma or liposarcoma, randomly assigned to receive either trabectedin (345 patients) or dacarbazine (173 patients). Median progression-free survival was 4.2 months for those in the trabectedin arm, compared with 1.5 months for those in the dacarbazine arm, according to an Oct. 23 statement issued by the FDA.

The most common side effects for those in the trabectedin arm were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.

The drug label carries a warning of the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Women should be advised of potential risks to a developing fetus, and those who are breastfeeding should not take trabectedin, the FDA said.

Trabectedin, an alkylating drug, is marketed as Yondelis by Janssen Products of Raritan, N.J.

The label is available on the FDA website at drugsatfda.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has approved trabectedin for the treatment of advanced or unresectable liposarcomas and leiomyosarcomas that have been previously treated with anthracycline-based regimens.

Approval is based on improvements in progression-free survival in a trial of 518 participants with metastatic or recurrent leiomyosarcoma or liposarcoma, randomly assigned to receive either trabectedin (345 patients) or dacarbazine (173 patients). Median progression-free survival was 4.2 months for those in the trabectedin arm, compared with 1.5 months for those in the dacarbazine arm, according to an Oct. 23 statement issued by the FDA.

The most common side effects for those in the trabectedin arm were nausea, fatigue, vomiting, diarrhea, constipation, decreased appetite, dyspnea, headache, peripheral edema, neutropenia, thrombocytopenia, anemia, elevated liver enzymes, and decreases in albumin.

The drug label carries a warning of the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy. Women should be advised of potential risks to a developing fetus, and those who are breastfeeding should not take trabectedin, the FDA said.

Trabectedin, an alkylating drug, is marketed as Yondelis by Janssen Products of Raritan, N.J.

The label is available on the FDA website at drugsatfda.

[email protected]

On Twitter @NikolaidesLaura

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FDA approves liposomal irinotecan for advanced pancreatic cancer

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The Food and Drug Administration approved irinotecan liposome injection, in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The approval, granted after a priority review, was based on results from a three-arm, randomized, open-label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after receiving a gemcitabine-based therapy. Median survival for patients treated with irinotecan liposome injection plus fluorouracil/leucovorin was 6.1 months, compared with 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only irinotecan liposome injection, compared with those who received fluorouracil/leucovorin, according to an Oct. 22 statement issued by the FDA.

The safety of irinotecan liposome injection was evaluated in 398 patients who received either the injection with fluorouracil/leucovorin, the injection alone, or fluorouracil/leucovorin. The most common side effects of irinotecan liposome injection included diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, pyrexia, lymphopenia, and neutropenia. The FDA warned that death due to sepsis following neutropenia has been reported in patients treated with irinotecan liposome injection, and labeling for the drug includes a boxed warning about the risks of severe neutropenia and diarrhea. The injection is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.

Irinotecan liposome injection, designated as an orphan drug, is being marketed as Onivyde by Merrimack Pharmaceuticals of Cambridge, Mass.

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On Twitter @NikolaidesLaura

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The Food and Drug Administration approved irinotecan liposome injection, in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The approval, granted after a priority review, was based on results from a three-arm, randomized, open-label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after receiving a gemcitabine-based therapy. Median survival for patients treated with irinotecan liposome injection plus fluorouracil/leucovorin was 6.1 months, compared with 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only irinotecan liposome injection, compared with those who received fluorouracil/leucovorin, according to an Oct. 22 statement issued by the FDA.

The safety of irinotecan liposome injection was evaluated in 398 patients who received either the injection with fluorouracil/leucovorin, the injection alone, or fluorouracil/leucovorin. The most common side effects of irinotecan liposome injection included diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, pyrexia, lymphopenia, and neutropenia. The FDA warned that death due to sepsis following neutropenia has been reported in patients treated with irinotecan liposome injection, and labeling for the drug includes a boxed warning about the risks of severe neutropenia and diarrhea. The injection is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.

Irinotecan liposome injection, designated as an orphan drug, is being marketed as Onivyde by Merrimack Pharmaceuticals of Cambridge, Mass.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration approved irinotecan liposome injection, in combination with fluorouracil and leucovorin, to treat patients with metastatic pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

The approval, granted after a priority review, was based on results from a three-arm, randomized, open-label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after receiving a gemcitabine-based therapy. Median survival for patients treated with irinotecan liposome injection plus fluorouracil/leucovorin was 6.1 months, compared with 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only irinotecan liposome injection, compared with those who received fluorouracil/leucovorin, according to an Oct. 22 statement issued by the FDA.

The safety of irinotecan liposome injection was evaluated in 398 patients who received either the injection with fluorouracil/leucovorin, the injection alone, or fluorouracil/leucovorin. The most common side effects of irinotecan liposome injection included diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, pyrexia, lymphopenia, and neutropenia. The FDA warned that death due to sepsis following neutropenia has been reported in patients treated with irinotecan liposome injection, and labeling for the drug includes a boxed warning about the risks of severe neutropenia and diarrhea. The injection is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.

Irinotecan liposome injection, designated as an orphan drug, is being marketed as Onivyde by Merrimack Pharmaceuticals of Cambridge, Mass.

[email protected]

On Twitter @NikolaidesLaura

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Look for tweaks to RAI, genomic analyses, and targeted treatment for thyroid cancer at ATA

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Look for tweaks to RAI, genomic analyses, and targeted treatment for thyroid cancer at ATA

Sessions during the upcoming 15th International Thyroid Congress and annual meeting of the American Thyroid Association will be hitting several hot topics in the treatment of thyroid cancer, including refinement of radioactive iodine treatment, genomic analyses, and targeted treatment. Investigators will be presenting data on the impact of RET and RAS mutation status on overall survival in the EXAM trial, a phase III study of cabozantinib in patients with progressive, metastatic medullary thyroid cancer (Abstract #51).

Investigators will present anticipated results from another phase III study looking at outcomes by site of metastasis for patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib vs. placebo (Abstract #55). A comparison of empiric fixed dosing with a whole body/blood clearance dosimetry-based management approach to radioactive iodine treatment in patients with radioiodine-avid distant metastases from differentiated thyroid cancer is also highly anticipated (Abstract #52) at the 85th Annual Meeting of the AT

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Of note, several sessions (abstract 89), including an plenary presentation by Dr. Shigenobu Nagataki on “Radiation and the Thyroid: From Nagasaki/Hiroshima, Chernobyl to Fukushima.” Dr. Nagataki, who is professor emeritus at Nagasaki (Japan) University School of Medicine, will focus on lessons learned about mass exposure to radiation from these catastrophes. The meeting is being held jointly in Lake Buena Vista, Fla., with the 15th International Thyroid Congress, Oct. 18-23.

Beyond thyroid cancer, investigators will present an analysis of the TACT (Taxotere as Adjuvant Chemotherapy) trial, looking at thyroid autoimmunity as a biomarker of outcome in women with breast cancer (Abstract #23) and a look at second primary malignancies among patients with post-Chernobyl papillary thyroid carcinoma (Abstract #53).

A full look at the program can be found here.

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On Twitter @NikolaidesLaura

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Sessions during the upcoming 15th International Thyroid Congress and annual meeting of the American Thyroid Association will be hitting several hot topics in the treatment of thyroid cancer, including refinement of radioactive iodine treatment, genomic analyses, and targeted treatment. Investigators will be presenting data on the impact of RET and RAS mutation status on overall survival in the EXAM trial, a phase III study of cabozantinib in patients with progressive, metastatic medullary thyroid cancer (Abstract #51).

Investigators will present anticipated results from another phase III study looking at outcomes by site of metastasis for patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib vs. placebo (Abstract #55). A comparison of empiric fixed dosing with a whole body/blood clearance dosimetry-based management approach to radioactive iodine treatment in patients with radioiodine-avid distant metastases from differentiated thyroid cancer is also highly anticipated (Abstract #52) at the 85th Annual Meeting of the AT

SciePro / Science Source

Of note, several sessions (abstract 89), including an plenary presentation by Dr. Shigenobu Nagataki on “Radiation and the Thyroid: From Nagasaki/Hiroshima, Chernobyl to Fukushima.” Dr. Nagataki, who is professor emeritus at Nagasaki (Japan) University School of Medicine, will focus on lessons learned about mass exposure to radiation from these catastrophes. The meeting is being held jointly in Lake Buena Vista, Fla., with the 15th International Thyroid Congress, Oct. 18-23.

Beyond thyroid cancer, investigators will present an analysis of the TACT (Taxotere as Adjuvant Chemotherapy) trial, looking at thyroid autoimmunity as a biomarker of outcome in women with breast cancer (Abstract #23) and a look at second primary malignancies among patients with post-Chernobyl papillary thyroid carcinoma (Abstract #53).

A full look at the program can be found here.

[email protected]

On Twitter @NikolaidesLaura

Sessions during the upcoming 15th International Thyroid Congress and annual meeting of the American Thyroid Association will be hitting several hot topics in the treatment of thyroid cancer, including refinement of radioactive iodine treatment, genomic analyses, and targeted treatment. Investigators will be presenting data on the impact of RET and RAS mutation status on overall survival in the EXAM trial, a phase III study of cabozantinib in patients with progressive, metastatic medullary thyroid cancer (Abstract #51).

Investigators will present anticipated results from another phase III study looking at outcomes by site of metastasis for patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib vs. placebo (Abstract #55). A comparison of empiric fixed dosing with a whole body/blood clearance dosimetry-based management approach to radioactive iodine treatment in patients with radioiodine-avid distant metastases from differentiated thyroid cancer is also highly anticipated (Abstract #52) at the 85th Annual Meeting of the AT

SciePro / Science Source

Of note, several sessions (abstract 89), including an plenary presentation by Dr. Shigenobu Nagataki on “Radiation and the Thyroid: From Nagasaki/Hiroshima, Chernobyl to Fukushima.” Dr. Nagataki, who is professor emeritus at Nagasaki (Japan) University School of Medicine, will focus on lessons learned about mass exposure to radiation from these catastrophes. The meeting is being held jointly in Lake Buena Vista, Fla., with the 15th International Thyroid Congress, Oct. 18-23.

Beyond thyroid cancer, investigators will present an analysis of the TACT (Taxotere as Adjuvant Chemotherapy) trial, looking at thyroid autoimmunity as a biomarker of outcome in women with breast cancer (Abstract #23) and a look at second primary malignancies among patients with post-Chernobyl papillary thyroid carcinoma (Abstract #53).

A full look at the program can be found here.

[email protected]

On Twitter @NikolaidesLaura

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FDA expands use of nivolumab to non-squamous NSCLC

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FDA expands use of nivolumab to non-squamous NSCLC

The Food and Drug Administration approved nivolumab for the treatment of patients with metastatic non-squamous non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy, along with a companion diagnostic to detect PD-L1 protein expression levels.

The FDA approved nivolumab for patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March of this year. The October approval expands the use of nivolumab to include patients with non-squamous NSCLC.

The approval was based on improvement in overall survival (OS) in an international, multicenter, open-label, randomized trial comparing nivolumab to docetaxel in 582 patients with metastatic non-squamous NSCLC with progression on or after platinum-based chemotherapy, according to an Oct. 9 statement issued by the FDA.

Median OS was 12.2 months in patients treated with 3 mg/kg nivolumab every 2 weeks (n = 292) compared with 9.4 months in patients treated with 75 mg/m2 docetaxel every 3 weeks (n = 290). There was also a significant improvement in overall response rate in the nivolumab arm (19% vs 12%); the median response duration was 17 months in the nivolumab arm and 6 months in the docetaxel arm. There was no significant difference in progression-free survival. Patients with PD-L1 positive NSCLC had a greater survival benefit than did those with PD-L1 negative NSCLC, and therefore, the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels.

Serious adverse events were reported in 47 of the 292 patients in the nivolumab arm. The most common serious adverse events were pneumonia, pulmonary embolism, dyspnea, and pleural effusion. Immune-mediated adverse events included hypothyroidism/thyroiditis, rash, pneumonitis, diarrhea/colitis, hyperthyroidism, hepatitis, nephritis, limbic encephalitis, and polymyalgia rheumatica.

The most common grade 3-4 adverse reactions in the nivolumab arm were dyspnea, fatigue, pneumonia, pulmonary embolism, pleural effusion, hyperglycemia, respiratory failure, and pain. The most common grade 3-4 laboratory abnormalities included lymphopenia, hyponatremia, anemia, increased AST, and increased ALT, the FDA said.

This approval follows closely behind the accelerated approval of pembrolizumab to treat patients with metastatic NSCLC who have disease that has progressed after other treatments and tumors that express PD-L1. This anti–PD-L1 drug was also approved with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and the PD-L1 IHC 28-8 pharmDx test is marketed by Dako North America Inc. Full prescribing information is available here.

[email protected]

On Twitter @NikolaidesLaura

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The Food and Drug Administration approved nivolumab for the treatment of patients with metastatic non-squamous non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy, along with a companion diagnostic to detect PD-L1 protein expression levels.

The FDA approved nivolumab for patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March of this year. The October approval expands the use of nivolumab to include patients with non-squamous NSCLC.

The approval was based on improvement in overall survival (OS) in an international, multicenter, open-label, randomized trial comparing nivolumab to docetaxel in 582 patients with metastatic non-squamous NSCLC with progression on or after platinum-based chemotherapy, according to an Oct. 9 statement issued by the FDA.

Median OS was 12.2 months in patients treated with 3 mg/kg nivolumab every 2 weeks (n = 292) compared with 9.4 months in patients treated with 75 mg/m2 docetaxel every 3 weeks (n = 290). There was also a significant improvement in overall response rate in the nivolumab arm (19% vs 12%); the median response duration was 17 months in the nivolumab arm and 6 months in the docetaxel arm. There was no significant difference in progression-free survival. Patients with PD-L1 positive NSCLC had a greater survival benefit than did those with PD-L1 negative NSCLC, and therefore, the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels.

Serious adverse events were reported in 47 of the 292 patients in the nivolumab arm. The most common serious adverse events were pneumonia, pulmonary embolism, dyspnea, and pleural effusion. Immune-mediated adverse events included hypothyroidism/thyroiditis, rash, pneumonitis, diarrhea/colitis, hyperthyroidism, hepatitis, nephritis, limbic encephalitis, and polymyalgia rheumatica.

The most common grade 3-4 adverse reactions in the nivolumab arm were dyspnea, fatigue, pneumonia, pulmonary embolism, pleural effusion, hyperglycemia, respiratory failure, and pain. The most common grade 3-4 laboratory abnormalities included lymphopenia, hyponatremia, anemia, increased AST, and increased ALT, the FDA said.

This approval follows closely behind the accelerated approval of pembrolizumab to treat patients with metastatic NSCLC who have disease that has progressed after other treatments and tumors that express PD-L1. This anti–PD-L1 drug was also approved with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and the PD-L1 IHC 28-8 pharmDx test is marketed by Dako North America Inc. Full prescribing information is available here.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration approved nivolumab for the treatment of patients with metastatic non-squamous non–small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy, along with a companion diagnostic to detect PD-L1 protein expression levels.

The FDA approved nivolumab for patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March of this year. The October approval expands the use of nivolumab to include patients with non-squamous NSCLC.

The approval was based on improvement in overall survival (OS) in an international, multicenter, open-label, randomized trial comparing nivolumab to docetaxel in 582 patients with metastatic non-squamous NSCLC with progression on or after platinum-based chemotherapy, according to an Oct. 9 statement issued by the FDA.

Median OS was 12.2 months in patients treated with 3 mg/kg nivolumab every 2 weeks (n = 292) compared with 9.4 months in patients treated with 75 mg/m2 docetaxel every 3 weeks (n = 290). There was also a significant improvement in overall response rate in the nivolumab arm (19% vs 12%); the median response duration was 17 months in the nivolumab arm and 6 months in the docetaxel arm. There was no significant difference in progression-free survival. Patients with PD-L1 positive NSCLC had a greater survival benefit than did those with PD-L1 negative NSCLC, and therefore, the FDA also approved the PD-L1 IHC 28-8 pharmDx test to detect PD-L1 protein expression levels.

Serious adverse events were reported in 47 of the 292 patients in the nivolumab arm. The most common serious adverse events were pneumonia, pulmonary embolism, dyspnea, and pleural effusion. Immune-mediated adverse events included hypothyroidism/thyroiditis, rash, pneumonitis, diarrhea/colitis, hyperthyroidism, hepatitis, nephritis, limbic encephalitis, and polymyalgia rheumatica.

The most common grade 3-4 adverse reactions in the nivolumab arm were dyspnea, fatigue, pneumonia, pulmonary embolism, pleural effusion, hyperglycemia, respiratory failure, and pain. The most common grade 3-4 laboratory abnormalities included lymphopenia, hyponatremia, anemia, increased AST, and increased ALT, the FDA said.

This approval follows closely behind the accelerated approval of pembrolizumab to treat patients with metastatic NSCLC who have disease that has progressed after other treatments and tumors that express PD-L1. This anti–PD-L1 drug was also approved with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and the PD-L1 IHC 28-8 pharmDx test is marketed by Dako North America Inc. Full prescribing information is available here.

[email protected]

On Twitter @NikolaidesLaura

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FDA approves pembrolizumab for advanced NSCLC

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The Food and Drug Administration has granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) who have disease that has progressed after other treatments and tumors that express PD-L1. The anti–PD-L1 drug is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Pembrolizumab was approved to treat patients with advanced melanoma in 2014. The effectiveness of the immunotherapy for treating advanced NSCLC was demonstrated among 61 patients enrolled within a larger multicenter, open-label, multipart study, according to an Oct. 2 statement issued by the FDA. These patients had advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR), and they each had PD-L1–positive tumors based on the results of the 22C3 pharmDx diagnostic test.

The overall response rate was 41%, and the effect lasted between 2.1 and 9.1 months, the FDA said.

The most common side effects in 550 patients with advanced NSCLC included fatigue, decreased appetite, dyspnea, and cough. Severe immune-mediated side effects occurred involving the lungs, colon, and hormone-producing glands.

Pembrolizumab is marketed as Keytruda by Merck & Co., and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc.

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On Twitter @NikolaidesLaura

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The Food and Drug Administration has granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) who have disease that has progressed after other treatments and tumors that express PD-L1. The anti–PD-L1 drug is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Pembrolizumab was approved to treat patients with advanced melanoma in 2014. The effectiveness of the immunotherapy for treating advanced NSCLC was demonstrated among 61 patients enrolled within a larger multicenter, open-label, multipart study, according to an Oct. 2 statement issued by the FDA. These patients had advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR), and they each had PD-L1–positive tumors based on the results of the 22C3 pharmDx diagnostic test.

The overall response rate was 41%, and the effect lasted between 2.1 and 9.1 months, the FDA said.

The most common side effects in 550 patients with advanced NSCLC included fatigue, decreased appetite, dyspnea, and cough. Severe immune-mediated side effects occurred involving the lungs, colon, and hormone-producing glands.

Pembrolizumab is marketed as Keytruda by Merck & Co., and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc.

[email protected]

On Twitter @NikolaidesLaura

The Food and Drug Administration has granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) who have disease that has progressed after other treatments and tumors that express PD-L1. The anti–PD-L1 drug is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.

Pembrolizumab was approved to treat patients with advanced melanoma in 2014. The effectiveness of the immunotherapy for treating advanced NSCLC was demonstrated among 61 patients enrolled within a larger multicenter, open-label, multipart study, according to an Oct. 2 statement issued by the FDA. These patients had advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR), and they each had PD-L1–positive tumors based on the results of the 22C3 pharmDx diagnostic test.

The overall response rate was 41%, and the effect lasted between 2.1 and 9.1 months, the FDA said.

The most common side effects in 550 patients with advanced NSCLC included fatigue, decreased appetite, dyspnea, and cough. Severe immune-mediated side effects occurred involving the lungs, colon, and hormone-producing glands.

Pembrolizumab is marketed as Keytruda by Merck & Co., and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc.

[email protected]

On Twitter @NikolaidesLaura

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