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BAY 43-9006 receives fast track designation for metastatic kidney cancer review

WEST HAVEN, CONN., and RICHMOND, CALIF., April 5, 2004 -- Bayer Pharmaceuticals and Onyx Pharmaceuticals announced that BAY 43-9006 has been granted Fast Track status by the FDA. The compound is being evaluated for the treatment of metastatic renal cell carcinoma, or advanced kidney cancer.

Currently in Phase III clinical testing, BAY 43-9006 is a novel RAF kinase and VEGF inhibitor that prevents tumor growth by combining two anticancer activities: inhibition of tumor cell proliferation and tumor angiogenesis. Bay 43-9006 is being co-developed by Bayer and Onyx.
The Fast Track program is designed to expedite the review of drug compounds for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need for new therapeutic approaches. Having a Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there may be more frequent interactions with the FDA and there may be the possibility of a priority review, which could decrease the typical review period.

In clinical trials, BAY 43-9006, a novel investigational drug candidate, demonstrated both anti-proliferative and anti-angiogenic properties -- two important anticancer activities. In preclinical models, BAY 43-9006 inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the level of RAF kinase. BAY 43-9006 also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signaling cascades.

Sources: Bayer & Onyx

Posted: April 2004