Update: Bayer gets first, US, approval for Nexavar

In a move that puts it ahead in the race to get new oncology drugs onto the US market, Germany's Bayer Healthcare has received the first marketing approval for its advanced renal cell cancer drug Nexavar (sorafenib, co-developed with US firm Onyx Pharmaceuticals), from the Food and Drug Administration.

The clearance was faster-than-expected, according to Bayer, which, along with Onyx, said on December 21 that they expect that Nexavar will be shipped, primarily to specialty pharmacies, and available to patients in the USA "within the next 24 hours." The drug will be priced at $4,333 per month of treatment (at wholesale acquisition price). The FDA decision had been expected on January 11, and its clearance was made with no restriction to refractory patients.

At its recent R&D presentation, Bayer raised its sales forecast on the drug to 1.0 billion euros ($1.2 billion), noting that it was to be filed for an additional indication of lung cancer (Marketletter December 19, 2005).