The Food and Drug Administration has expanded the approved use of Cyramza (ramucirumab) for the treatment of patients with metastatic non-small cell lung cancer. Cyramza, an angiogenesis inhibitor that blocks the blood supply to tumors, is intended for patients whose tumor has progressed during or following treatment with platinum-based chemotherapy. Cyramza is to be used in combination with docetaxel.
Cyramza was also approved earlier this year as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma (OT 5/25/14 issue). That indication was expanded in November to include the chemotherapy paclitaxel with that use for Cyramza (OT 12/10/14 issue).
"Today's approval is the third indication that Cyramza has received in 2014," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. "The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients."
Cyramza's latest approval is based on a clinical study of 1,253 patients with previously treated and progressive lung cancer who were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Median overall survival for patients treated with Cyramza plus docetaxel was 10.5, compared with 9.1 months for the patients who received placebo plus docetaxel. Treatment was stopped for the other patients in the trial due to disease progression or intolerable side effects.
"By adding ramucirumab [Cyramza] to docetaxel, patients were able to live longer than those who were treated with the standard approach," the study's principal investigator, Edward Garon, MD, a researcher at UCLA's Jonsson Comprehensive Cancer Center, said in a UCLA news release. "We are pleased to have access to a drug that lengthens survival time in a population of lung cancer patients who often have few treatment options."
The most common side effects associated with Cyramza plus docetaxel from the study were neutropenia, fatigue, and stomatitis. Cyramza can also cause severe bleeding, blood clots, elevation in blood pressure, and may impair wound healing.
The FDA reviewed Cyramza's application for this new use under the agency's priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
Cyramza is marketed by Eli Lilly.