Onyx Pharmaceuticals was delayed a bit in its quest to start selling another cancer drug in the U.S., but now it has gotten its application together and hit the ball into the FDA’s court.
South San Francisco-based Onyx Pharmaceuticals (NASDAQ: ONXX) said today it has turned in its application to start selling carfilzomib in the U.S. as a new treatment for multiple myeloma, a deadly cancer of the bone marrow. The company has asked the FDA for a faster-than-usual six-month regulatory review, which the agency sometimes grants to drugs with lifesaving potential.
This drug is a big deal for Onyx, as it seeks to add a second revenue stream after its original success with the cancer drug sorafenib (Nexavar) for kidney and lung tumors. The new product, which Onyx obtained through the 2009 acquisition of South San Francisco-based Proteolix, is a proteasome inhibitor that investors are hoping will beat a blockbuster myeloma drug from the same class sold by Millennium: The Takeda Oncology Company. Onyx’s application hinges on a study of 266 patients in which tumors shrank by at least half in 24 percent of the sickest patients with myeloma, who had already gotten at least two rounds of prior therapy.
Onyx said last October it needed to delay its application because of some issues with scaling up manufacturing, which it said at the time that it hoped to resolve by “as early as mid-2011.” Now it will be up to the agency to formally accept the application for review, and set a legal deadline to say whether the new drug is ready for the marketplace, sometime in 2012.
Cory Kasimov, an analyst with JP Morgan, said in a note to clients this morning that the FDA will almost certainly convene a public advisory panel of cancer drug experts to scrutinize the drug. He said there’s about a 60 percent chance that the drug will win the kind of accelerated approval Onyx is asking for, and some chance that the drug could be delayed as the FDA asks for more information or clinical trial commitments. Onyx has a couple of larger studies, known as Aspire and Focus, which could help confirm the results seen in the earlier trial of 266 patients.
“We believe carfilzomib approval is a question of when, not if,” Kasimov wrote.
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