FDA reject Taltorvic (Merck Inc) for Sarcomas

The FDA has issued a complete response letter to an application for Sarcoma drug Taltorvic (ridaforolimus), from Merck Inc., saying it cannot approve the application in its present form, and "that additional clinical trial(s) would need to be conducted to further assess safety and efficacy". The rejection follows a vote in March in which the agency's Oncologic Drugs Advisory Committee voted 13 to one against approval. Merck is in ongoing discussions with European regulators.