Bayer kidney cancer compound given Fast Track status

A compound being evaluated for the treatment of metastatic renal cell carcinoma, BAY 43-9006, has been granted Fast Track status by the US FDA.

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 tumor cell proliferation and tumor angiogenesis. Bay 43-9006 is being co-developed by Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals.

In preclinical models, BAY 43-9006 inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signalling pathway at the level of RAF kinase. It also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signalling cascades.

'The recent FDA action underscores the need for new therapeutic options for people with metastatic renal cell carcinoma,' said Dr Susan Kelley, 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 and we look forward to compiling the data generated from this trial and submitting it to the FDA.'