Taltorvic ridaforolimus regulatory update

FDA issued a complete response letter for an NDA from Merck for ridaforolimus as maintenance therapy for metastatic soft tissue or bone sarcoma patients with stable disease following chemotherapy. According to Merck, FDA requested additional trials. In March, FDA's Oncologic Drugs Advisory Committee voted 13-1 that ridaforolimus did not demonstrate a favorable benefit-risk profile (see BioCentury, March 26). ...