Oncopeptides’ Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says

23 Sep 2022

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.

Dim room — Pepaxto's near-term future in the US appears dim following a strongly negative advisory committee vote. • Source: Shutterstock

Oncopeptides’ Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says

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