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The ODAC Losing Streak Ends

Executive Summary

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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Genentech’s Polivy Gets US FDA Panel Nod For First-Line Use In Large B-Cell Lymphoma

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.

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.

GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement

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.

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