Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced that BAY 43-9006 has been granted Fast Track status by the U.S. Food and Drug Administration (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 tumour growth by combining two anticancer activities: inhibition of tumour cell proliferation and tumour 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.
“The recent FDA action underscores the need for new therapeutic options for people with metastatic renal cell carcinoma,” said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation.” Bayer and Onyx are engaged in a large pivotal Phase III study examining the efficacy and safety of BAY 43-9006 in this patient population. We look forward to compiling the data generated from this trial and submitting it to the FDA.”
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 tumour 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.
Renal cell carcinoma is the most common form of kidney cancer. Median survival for patients with advanced metastatic kidney cancer is estimated at eight to 12 months. Approximately 32,000 people in the U.S. are diagnosed with kidney cancer annually, and about 12,000 Americans die each year from this cancer.