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 – the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer. Results from the trial have so far shown that sorafenib doubled progression-free survival when compared to those patients who received placebo.
Sorafenib is currently available to patients throughout the US through a treatment protocol known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study.
“New treatment options are clearly needed for people with advanced kidney cancer,” said Wolfgang Plischke, president of Bayer HealthCare’s Global Pharmaceutical Division. “We were encouraged by our phase III results, as we are now with the completion of the NDA filing.”