The ODAC Losing Streak Ends
US FDA’s Oncologic Drugs Advisory Committee’s endorsement of a first-line indication for Genentech’s Polivy is the first time the panel has voted ‘yes’ on a cancer drug application in almost three years.
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Advisory committee members were swayed by a progression-free survival benefit, and the reduction in salvage therapies, with a polatuzumab-containing regimen relative to the highly effective standard of care in the POLARIX trial.
Citing a ‘modest’ progression-free survival benefit and no improvement in overall survival in the Phase III POLARIX trial, US FDA is asking its Oncologic Drugs Advisory Committee whether polatuzumab vedotin’s current third-line indication should be expanded to first-line use in diffuse large B-cell lymphoma.
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.