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Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.
The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.
Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.
“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.
The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.
Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.
The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m2 IV) administered every 3 weeks.
NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.
Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.
Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.
The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.
Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.
“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.
The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.
Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.
The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m2 IV) administered every 3 weeks.
NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.
Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.
Ramucirumab, a vascular endothelial growth factor receptor 2 antagonist, has been approved for treating aggressive non-small cell lung cancer, the third indication approved for the agent in 2014, the Food and Drug Administration announced Dec. 12.
The approved indication is for ramucirumab, in combination with docetaxel, for “the treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy,” according to the updated prescribing information. The indication includes the statement that “patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations” before they are treated with ramucirumab.
Ramucirumab, marketed as Cyramza by Eli Lilly, was initially approved in April as a treatment for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma, as a single agent after prior fluoropyrimidine or platinum-containing therapy. In November, it was approved in combination with paclitaxel, as a treatment for patients with advanced gastric or GEJ adenocarcinoma, with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.
“The commitment to study [ramucirumab] in a variety of malignancies provides important treatment options to patients,” Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research said in a statement.
The latest indication was approved based on a multicenter, double-blind, placebo-controlled study of 1,253 people with previously treated metastatic NSCLC, randomized to treatment with ramucirumab plus docetaxel or docetaxel plus placebo, administered until disease progressed or they developed intolerable adverse effects. Median overall survival among those treated with ramucirumab was 10.5 months vs. 9.1 months among those on docetaxel alone, a statistically significant difference (hazard ratio, 0.86, P = .024). In addition, progression-free survival was significantly longer (P less than .001), according to the FDA.
Neutropenia, stomatitis, and fatigue were among the most common adverse events associated with treatment. The drug’s label included a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events, associated with treatment.
The recommended dosing for the NSCLC indication is ramucirumab (10 mg/kg intravenously) and docetaxel (75 mg/m2 IV) administered every 3 weeks.
NSCLC is the most common type of lung cancer and will be diagnosed in 224,210 people in the United States in 2014, according to National Cancer Institute estimates cited in the FDA statement.
Serious adverse events associated with ramucirumab and any other medication or device should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/report.htm.
