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news.Bayer Pharmaceuticals and Onyx Pharmaceuticals' anticancer therapy sorafenib has been accepted into the FDA's Pilot 1 program for continuous marketing applications.
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Sorafenib is a novel investigational drug candidate that has targeted members of two classes of kinases known to be involved in both tumor growth and tumor blood supply – two important cancer growth activities – in preclinical models.
The Pilot 1 program was designed for therapies that have been granted fast track status by the FDA and that have the potential to provide important therapeutic benefit over available therapy. Sorafenib (formerly BAY 43-9006) was granted fast track status for metastatic renal cell carcinoma (RCC), or kidney cancer, in March 2004.
As one of the Prescription Drug User Fee Act (PDUFA) goals, the Pilot 1 program is intended to expedite the continuous marketing application (CMA) concept. As part of the program, companies submit portions of an application before submitting the complete new drug application (NDA). The FDA agrees to complete review of these sections within a specified period of time and to provide early feedback to the applicant.
Bayer and Onyx are currently preparing a NDA for sorafenib and, if approved, hope to make the treatment available in the first half of 2006.