FDA Approves Ramucirumab for Non-small Cell Lung Cancer

Roxanne Nelson


December 12, 2014

The US Food and Drug Administration (FDA) today expanded the indication of ramucirumab (Cyramza, Eli Lilly) to include the treatment of metastatic non-small cell lung cancer (NSCLC).

Earlier this year, the drug was approved for the treatment of gastric cancer, as both a monotherapy and in combination with paclitaxel.

Ramucirumab is a fully human monoclonal antibody that was developed for the treatment of solid tumors. It is a vascular endothelial growth-factor receptor 2 (VEGFR) antagonist that specifically binds and blocks activation of that receptor.

"Today's approval is the third indication that ramucirumab has received in 2014," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research, in a statement. "The commitment to study ramucirumab in a variety of malignancies provides important treatment options to patients."

The approval is based on findings from the phase 3 REVEL trial, an international study that involved 1253 patients with nonsquamous and squamous cell NSCLC from 26 countries on six continents (Lancet. 2014;384:665-673).

The study compared ramucirumab plus docetaxel with placebo plus docetaxel in NSCLC patients who experienced disease progression after treatment with platinum-based chemotherapy for locally advanced or metastatic disease.

Overall survival was 1.4 months longer with ramucirumab than with placebo.

Median overall survival was better in the ramucirumab group than in the placebo group (10.5 vs 9.1 months; hazard ratio [HR], 0.857; P = .0235), as was median progression-free survival (4.5 vs 3.0 months; HR, 0.762; P < .0001).

The overall response rate was also better in the ramucirumab group (23% vs 14%; P < .0001).

"The improvement of overall survival and progression-free survival in the ramucirumab-plus-docetaxel arm was also consistent across the majority of subgroups, including histology," said Maurice Pérol, MD, from the Léon-Bérard Cancer Centre in Lyon, France, who was colead investigator of the REVEL study, in a statement.

"Overall, these results are very encouraging for those of us who treat lung cancer patients," he said.

According to the manufacturer, the most common grade 3 and higher adverse events, which occurred more frequently in patients in the ramucirumab than in the placebo group, were neutropenia (48.8% vs 39.8%), febrile neutropenia (15.9% vs 10.0%), fatigue (14.0% vs 10.5%), leukopenia (13.7% vs 12.5%), and hypertension (5.6% vs 2.1%). Grade 5 adverse events were comparable in the ramucirumab and placebo groups (5.4% vs 5.8%).

Patients in the ramucirumab group experienced more bleeding/hemorrhage events of any grade than those in the placebo group (28.9% vs 15.2%), but the rate of grade 3 or higher bleeding/hemorrhage events was similar in the two groups (2.4% vs 2.3%).

The application for this new indication was reviewed under the FDA's priority review program, which provides for expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared with marketed products.


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