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Home » BAYER AND ONYX COMPLETE FILING OF NDA FOR SORAFENIB
BAYER AND ONYX COMPLETE FILING OF NDA FOR SORAFENIB
Bayer Pharmaceuticals and Onyx Pharmaceuticals announced that the companies have completed the submission of a New Drug Application (NDA) with the FDA for sorafenib (BAY 43-9006) for patients with advanced renal cell carcinoma, or kidney cancer.
Sorafenib was accepted by the FDA into the Pilot 1 Program for continuous marketing applications. The Pilot 1 Program was designed for therapies that have been granted fast-track status and have the potential to provide important therapeutic benefit over available therapies. Under the Pilot 1 Program designation, the FDA is committed to reviewing each "reviewable unit" of the submission within a six month timeframe.
The sorafenib submission is based on an ongoing Phase III trial in patients with advanced kidney cancer. Results from the study - the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer - were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).
KEYWORDS Drug Pipeline Alert
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