Developer: Onyx Pharmaceuticals
Lead indication: Multiple myeloma
Key date: July 27 PDUFA date
Onyx Pharmaceuticals ($ONXX) suffered a setback in its pursuit of FDA approval of carfilzomib last year when U.S. regulators balked at the company's request for priority review of the experimental cancer drug as a treatment for multiple myeloma. The FDA decided that Onyx lacked trial data to support a speedy review grant, but some analysts believe that in the drug is destined for approval.
South San Francisco-based Onyx has championed carfilzomib--which targets the protein complex known as the proteasome to weaken tumors--as an advanced attack on plasma cancers that reduces nerve damage associated with existing therapies. In a Phase II study, nearly a quarter of patients on the drug who failed previous treatment had at least a partial response to Onyx's drug.
Onyx, which markets the blockbuster cancer drug Nexavar with Bayer, has been shortlisted as an acquisition target for asset-minded biopharma groups that aim to boost their product offerings. With competition to Nexavar growing, there's added pressure for the company to deliver a new product onto the market. Obviously, an FDA approval of carfilzomib this summer would have a positive impact on the company and could prompt a buyer to pull the trigger on an acquisition offer.
The FDA has an action date of July 27 for Onyx's application to sell carfilzomib to treat multiple myeloma.