The FDA has approved the combination of ramucirumab and docetaxel for the treatment of patients with metastatic non-small-cell lung cancer.
The US Food and Drug Administration has approved the combination of ramucirumab (Cyramza) and docetaxel on Friday for the treatment of patients with metastatic non-small-cell lung cancer (NSCLC), specifically after disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations should have progression while on approved therapy for those aberrations. This follows earlier approvals of ramucirumab this year for the treatment of advanced gastric or gastroesophageal junction cancer as well.
The approval of ramucirumab in NSCLC is based upon results of a large phase III trial known as REVEL, results of which were presented earlier this year at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. That trial, led by Maurice PÃ©rol, MD, of the Cancer Research Center of Lyon in France, included 1,253 patients randomized to either docetaxel and ramucirumab or docetaxel and placebo.
The median overall survival in the ramucirumab arm was 10.5 months, compared with 9.1 months in the placebo arm. This resulted in a hazard ratio for death of 0.86 (95% CI, 0.75-0.98; P = .024). Progression-free survival was also significantly improved with ramucirumab, with an HR of 0.76 (95% CI, 0.68-0.86; P < .001).
Safety was evaluated in 1,245 of the patients in the study, and the drug had an acceptable toxicity profile. The most frequently report adverse events included neutropenia, fatigue, and stomatitis.
The FDA’s new approval is for a recommended dose and schedule of 10 mg/kg IV ramucirumab and 75 mg/m2 IV docetaxel, administered once every 3 weeks. Ramucirumab is a fully human monoclonal antibody against the VEGF Receptor 2, which inhibits angiogenesis.
Ramucirumab has been and continues to undergo testing in a variety of malignancies. The drug showed promise in combination with paclitaxel in a phase III trial of metastatic gastric cancer, and is in various stages of phase III trials in colorectal cancer, hepatocellular carcinoma, and breast cancer as well.