News Feature | December 17, 2014

Lilly's Cyramza Approved By FDA For Aggressive NSCLC

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) announced that it has approved the expanded use of Eli Lilly’s drug Cyramza (ramucirumab) as treatment for metastatic non-small cell lung cancer (NSCLC).

Cyramza is an angiogenesis inhibitor intended to eliminate the formation of new blood vessels, in turn cutting off tumors’ blood supply and nourishment. The FDA approved Cyramza for patients with NSCLC whose tumor has developed in spite of current or post-treatment with platinum-based chemotherapy. The drug is to be used as combination therapy with docetaxel for the indication.

Lilly received two previous approvals for Cyramza this year. In April, the FDA granted approval for Cyramza as monotherapy for gastroesophageal junction (GEJ) adenocarcinoma under an Orphan Drug Designation. Last month, the company received approval for expanded use as treatment for advanced gastric or GEJ adenocarcinoma to include paclitaxel.

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

The approval was based on the positive results of a clinical study involving 1,253 patients with previously treated and aggressive lung cancer. Data showed that half of patients treated with Cyramza plus docetaxel survived for an average of 10.5 months compared to those who took placebo plus docetaxel, which recorded an average of 9.1 months.

Non-small cell lung cancer is the leading type of lung cancer, which results from the formation of cancer cells in the lung. According to the National Cancer Institute, an estimated 224,210 people in the U.S. will be diagnosed with NSCLC this year, while 159,260 will succumb to the disease.

Coincidentally, with this year’s triple approval, the company also reached its highest stock value in 10 years at $75.10 last week.