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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Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.