Thumbs down for Merck & Co and Ariad sarcoma drug Taltorvic from FDA advisory

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC) yesterday voted by 13 to one against approving Taltorvic (ridaforolimus), from US drug giant Merck & Co (NYSE: MRK) and partner Ariad Pharmaceuticals (Nasdaq: ARIA), as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.

The ODAC concluded that the short-term benefits offered by Taltorvic did not outweigh the risks of adverse reactions and a lack of evidence of improved overall survival. The panel also raised concerns about the drug's side effects, with 60% of patients experiencing a serious drug-related issue.

The same advisory panel voted in favor of approving rival sarcoma drug Votrient (pazopanib) from GlaxoSmithKline (see separate story today). The FDA is not bound by the panel’s recommendation, and is scheduled to give its final decision on Taltorvic by June 5.