New drug application submitted for RCC agent

July 21, 2005

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc., have submitted a new drug application with the FDA for sorafenib for patients with advanced renal cell carcinoma. Submission is based on an ongoing phase III trial suggesting that the drug doubled progression-free survival compared with patients receiving placebo.

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc., have submitted a new drug application with the FDA for sorafenib for patients with advanced renal cell carcinoma. Submission is based on an ongoing phase III trial suggesting that the drug doubled progression-free survival compared with patients receiving placebo. Survival was doubled to a median value of 24 weeks in patients receiving the therapy compared with 12 weeks for patients receiving placebo (p<.000001).

Thus far, 769 patients have been evaluated for safety. Drug-related adverse events were similar to those observed in previous clinical trials, the manufacturers said.