FDA Panel Splits Recommendations on Sarcoma Drugs

A U.S. Food and Drug Administration advisory panel recommended GlaxoSmithKline Plc's Votrient for soft-tissue sarcoma on Tuesday, but did not recommend a treatment for the same malady developed jointly by Merck & Co Inc and Ariad Pharmaceuticals Inc.

The FDA committee of outside experts voted 11-2 in finding that Votrient's ability to improve short-term survival without worsening symptoms in patients who receive chemotherapy outweighed adverse risks and a lack of evidence that it can extend overall survival.

The same panel voted 13-1 not to recommend Merck's drug Taltorvic for soft-tissue and bone sarcoma after reviewing data that associated the drug with serious adverse effects but produced only small improvements in patients who had completed at least four cycles of chemotherapy.

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Source: Reuters