Onyx Delays Cancer Drug Application as FDA Asks for More Data on Manufacturing
Summary
Onyx Delays Cancer Drug Application as FDA Asks for More Data on Manufacturing Xconomy San Francisco — Some minor bad news came out this afternoon from Onyx Pharmaceuticals, and its lead drug candidate for patients with multiple myeloma.The Emeryville, CA-based drug developer said today it is delaying the new drug application for carfilzomib after FDA officials asked for more data to show it can manufacture larger commercial batches that are consistent with the molecules it produced and tested in clinical trials.Onyx has generated some data already, and is working to produce more, to show its larger-scale process is reproducible and creates a product with the same properties that were observed in the clinical trials.The new drug is vitally important to Onyx’s growth prospects, as it seeks to diversify beyond its lone marketed product at the moment, sorafenib (Nexavar) for kidney and liver cancer.A few months later, in July, Onyx reported that the new drug helped shrink tumors in about one-fourth of patients who had relapsed after getting prior rounds of treatment.