FDA approves Bayer, Onyx’s Stivarga for colorectal cancer

The FDA on Thursday approved Bayer and Onyx Pharmceuticals Stivarga (regorafenib) to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after standard therapy. The therapy, which was evaluated under the agency’s priority review programme, was approved ahead of an anticipated October 27 deadline.

The decision was based on data form the Phase III CORRECT study, which was halted in October after an interim analysis showed that the oral multi-kinase inhibitor significantly improved overall survival compared to best supportive care alone in this patient population. Specifically, patients given Bayer and Onyx’s drug lived for an average of 6.4 months, versus approximately 5 months for patients given best supportive care alone. In addition, patients treated with Stivarga experienced a delay in tumor growth for a median of two months, compared to a median of 1.7 months in patients receiving best supportive care alone.

"Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months," remarked Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. In August, the agency approved Sanofi and partner Regeneron Pharmaceuticals' Zaltrap (aflibercept) as a second-line therapy for use in combination with chemotherapy for patients with mCRC who have failed to respond to an oxaliplatin-based chemotherapy regimen.

In August, Bayer also filed for FDA approval of the therapy to treat metastatic and/or unresectable gastrointestinal stromal tumours (GIST) in patients whose disease has progressed despite prior treatment. Bayer has suggested that the drug has the potential to reach peak annual sales of 1 billion euros ($1.3 billion) with multiple approved uses. Under the terms of a 2011 agreement, the companies will co-promote the agent in the US, with Onyx eligible to receive a 20 percent royalty on global net sales of the therapy in oncology.

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