Phase III Trial Of Bayer/Onyx Regorafenib Stopped Early For Efficacy
This article was originally published in The Pink Sheet Daily
Interim analysis revealed the trial in advanced metastatic colorectal cancer had already met the overall survival endpoint.
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The high cost of colon cancer drugs is once again under fire, this time with Bayer and Onyx in the hot seat. In a Lancet editorial accompanying pivotal trial results for regorafenib, U.K. authors doubt the modestly efficacious drug will ever prove cost-effectiveness in colon cancer, but that its role in GIST looks more compelling.
Ahead of schedule, FDA approves Stivarga (regorafenib), partnered with Onyx, for late-stage mCRC patients with few options left. Bayer prices drug at under $10,000 a month, on par with competing treatments.
Erbitux wins FDA approval for first-line metastatic colorectal cancer negative for KRAS mutations detected with a companion diagnostic specifically approved for the drug. In theory, earlier use could help shore up sales. But the drug faces a tough competitor in the dominant Avastin and new products are on the near horizon.