Oncopeptides AB should conduct a prospective, randomized trial to identify an appropriate patient population for Pepaxto (melphalan flufenamide, or melflufen) because the multiple myeloma drug’s benefit-risk profile in its current indication is not favorable, a US Food and Drug Administration panel said on 22 September.
Oncopeptides’ Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says
Advisory committee votes 14-2 that melflufen’s benefit-risk profile is unfavorable in the current accelerated approval indication for fifth-line treatment of multiple myeloma; panel rejects sponsor’s attempt to rely on post hoc analyses to 'carve out' a subpopulation that, it asserts, is responsible for negative overall survival trend in OCEAN confirmatory trial.
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