Taltorvic ridaforolimus regulatory update

EMA's CHMP provided a list of questions and answers related to a withdrawn MAA from Merck for ridaforolimus as maintenance therapy for patients with soft tissue sarcoma or primary malignant bone tumor. CHMP said that at the time the application was withdrawn it was of the opinion the benefits of ridaforolimus did not outweigh the risks. The committee said it considered the progression-free survival (PFS) benefit seen with ridaforolimus to be "modest." CHMP also said it was concerned about the high frequency of adverse events and the "uncommon but potentially life-threatening" side effects.

Last month, Merck withdrew the MAA for ridaforolimus and said that CHMP had determined the data were "not sufficient" for approval based on a provisional opinion (see BioCentury, Dec. 3). At the time, 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). ...