Community Translations

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).¹ Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.²

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).¹ Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.²

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) has granted accelerated approval to blinatumomab for the treatment of adult patients with relapsed/ refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (BCP-ALL).¹ Blinatumomab is the first of a novel class of antibodies to receive regulatory approval; a bispecific antibody targeting both CD19, expressed on the surface of B cells, and CD3, on cytotoxic T cells. The approval was based on the findings of a single-arm, multicenter, open-label study in patients at high-risk of poor outcome, which showed a significant improvement of blinatumomab over other available therapies in this setting.²

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

Click on the PDF icon at the top of this introduction to read the full article.

The US Food and Drug Administration (FDA) recently approved NEPA, an oral fixed-dose combination of netupitant and palonosetron for treatment of chemotherapy-induced nausea and vomiting (CINV). Palonosetron is a pharmacologically distinct, best-in-class serotonin (5-hydroxytryptamine) type 3 (5-HT3) receptor antagonist, which prevents CINV during the acute phase (0-24 h) after administration of chemotherapy, and netupitant is a potent and selective neurokinin-1 (NK-1) receptor antagonist, which prevents CINV during both the acute and delayed (25-120 h) phases. The 2 agents have also been shown potentially to act synergistically in inhibiting NK-1 receptor activity.

Click on the PDF icon at the top of this introduction to read the full article.

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

Click on the PDF icon at the top of this introduction to read the full article.

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

Click on the PDF icon at the top of this introduction to read the full article.

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

Click on the PDF icon at the top of this introduction to read the full article.

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

Click on the PDF icon at the top of this introduction to read the full article.

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

Click on the PDF icon at the top of this introduction to read the full article.

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

Click on the PDF icon at the top of this introduction to read the full article.

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

Click on the PDF icon at the top of this introduction to read the full article.

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

Click on the PDF icon at the top of this introduction to read the full article.

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

Click on the PDF icon at the top of this introduction to read the full article.