Taltorvic ridaforolimus regulatory update

Merck withdrew an MAA in the EU for ridaforolimus as maintenance therapy for patients with soft tissue sarcoma or primary malignant bone tumor. According to the pharma, EMA's CHMP said based on a "provisional view" that the data for ridaforolimus were "not sufficient" for approval. Merck declined to discuss whether it would resubmit the MAA and said it is still evaluating whether to conduct additional trials for ridaforolimus that were requested by FDA in a June complete response letter; Merck has not disclosed details of the letter (see BioCentury, June 11). ...