This article is more than 5 years old. Information may no longer be current.
FDA expands approval of ramucirumab to treat aggressive NSCLC
Click Here to Manage Email Alerts
The FDA today announced the expanded approval of ramucirumab in the treatment of patients with metastatic non–small cell lung cancer.
Ramucirumab (Cyramza, Eli Lilly) is intended for patients who have had tumor progression during or after treatment with platinum-based chemotherapy, and should be used with docetaxel, another chemotherapy regimen.
“Today’s approval is the third indication that Cyramza has received in 2014,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation Research, said in a press release. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”
Richard Pazdur
NSCLC is the most common form of lung cancer, and the NCI estimates that 224,210 Americans will be diagnosed with the disease and 159,260 will have died of lung cancer by the end of 2014.
The FDA first approved ramucirumab as a single agent for the treatment of advanced stomach cancer or gastroesophageal junction adenocarcinoma in April.
In November, the FDA expanded the drug’s use to treat patients with advanced gastric or gastroesophageal junction adenocarcinoma to include paclitaxel.
This latest approval was based on a clinical study of 1,253 patients with previously treated and progressive lung cancer.
Patients were randomly assigned ramucirumab plus docetaxel or a placebo plus docetaxel. Treatment was administered until disease progression or the development of intolerable side effects.
With the endpoints of the trial designed to measure OS, results showed that patients receiving ramucirumab plus docetaxel survived an average of 10.5 months from the start of treatment compared with an average of 9.1 months for those who received the placebo.
The most common adverse effects observed in the study included neutropenia, as well as stomatitis. Ramucirumab also can cause blood clots, elevated blood pressure, sever bleeding and may impair the healing of wounds.
The FDA reviewed the application of this agent for this new use as part of the agency’s priority review program, which provides an expedited review of drugs that are intended to treat serious diseases or conditions and, if approved, would offer significant improvement as compared with currently marketed products.