Saturday, December 13, 2014

FDA expands approval of Cyramza to non-small cell lung cancer

CANCER DIGEST – Dec. 13, 2014 – The FDA today expanded the approved use of Cyramza® (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

Marketed by Eli Lily, Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for NSCLC patients whose tumors have grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.

On April 21, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

The approval of Cyramza plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive lung cancer,  Results showed that half of the participants treated with Cyramza plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.

The most common side effects associated with Cyramza plus docetaxel observed in the clinical study included a decrease in infection-fighting white blood cells called neutrophils (neutropenia) fatigue and inflammation of the lining of the mouth (stomatitis).

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