Onyx will seek early approval on blockbuster cancer candidate

The multiple myeloma therapy carfilzomib registered a response in about one of four drug-resistant patients in a mid-stage trial, reports Onyx Pharmaceuticals, which the biotech believes is solid enough data to win an accelerated approval for a therapy with clear blockbuster potential. Onyx CEO Anthony Coles told reporters that a regulatory filing will be made before the end of this year.

The Phase IIb data on the proteasome inhibitor is a big win for Onyx, which scooped up the therapy when it acquired Proteolix in an $816 million buyout deal--with $276 million up front--just a year ago. And Coles says the drug could be on the market a year from now for the lethal cancer. "The unmet need in the population is so huge and the disease is almost uniformly fatal," Coles told the San Francisco Business Times.

Researchers recruited 266 patients for the trial and found that 24 percent registered at least a partial response to the therapy. The median duration of response in patients was 7.4 months. But the company declined to say for now just how long patients taking the drug survived, notes the New York Times, waiting for the right scientific conference to detail that data. For now, the company will only say that it believes carfilzomib will prolong survival. Now Onyx's blockbuster hopes will shift to the Phase III stage. Two late-stage trials are planned for the drug, including one study that will examine the effects of a combination of a low dose of the steroid dexamethasone and Revlimid with and without carfilzomib. A European Phase III study is also planned.

As Forbes' Robert Langreth notes today, Onyx is anxious to score another blockbuster cancer drug approval to complement its success with Nexavar. Onyx has a unique status as the only sizeable standalone cancer drug developer, he adds, making the company a likely candidate for a rich buyout offer if it can come up with a new blockbuster therapy.

- here's the release on the data
- read the story from the San Francisco Business Times
- see the report from Forbes
- here's the story from the New York Times

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