US drug giant Merck & Co (NYSE: MRK) has received a complete response letter from the US Food and Drug Administration regarding the New Drug Application for ridaforolimus (proposed trade name Taltorvic), for which Merck obtained an exclusive license from Ariad Pharmaceuticals (Nasdaq: ARIA) for oncology indications, calling for additional clinical data.
Ridaforolimus is an investigational oral mTOR inhibitor under development for maintenance therapy for patients with metastatic soft tissue or bone sarcoma who have stable disease or better after four or more cycles of chemotherapy.
Decision follows negative advisory panel vote
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