FDA Green Lights Third Indication for Lilly’s Cancer Drug Cyramza
The FDA has approved Eli Lilly’s Cyramza to treat the most common type of lung cancer, the latest effort by the drugmaker to vastly increase uses of the oncology drug.
The approval indicates Cyramza (ramucirumab) combined with chemotherapy docetaxel for treating metastatic non-small cell lung cancer in patients whose tumor has progressed during or after treatment with platinum-based chemotherapy.
This is the third indication for Cyramza, which won approval in April as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a cancer that affects the region where the stomach and esophagus meet. Last month, the FDA approved Cyramza’s use in GEJ patients alongside the chemotherapy drug paclitaxel.
The latest indication was cleared through the agency’s priority review program and supported by a clinical trial of 1,253 participants with previously treated and progressive lung cancer.
Lilly plans to submit more indications for Cyramza. In the first half of 2015 it expects to submit an FDA application for Cyramza in combination with chemotherapy to treat metastatic colorectal cancer, according to the drugmaker’s latest financial report.
The drugmaker also tried to expand the indication to treat breast cancer, but the drug failed in a Phase III trial last year.
The push for new indications for Cyramza comes as the company continues to grapple with the loss of market exclusivity for blockbuster anxiety drug Cymbalta (duloxetine HCl) last December and osteoporosis treatment Evista (raloxifene) in March. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.