Genentech Polivy’s Benefit-Risk Profile In First-Line Lymphoma Under Scrutiny
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.
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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.
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.
But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.