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Genentech’s Polivy To Get US FDA Panel Review For First-Line Treatment Of Diffuse B-Cell Lymphoma

 
• By Sue Sutter

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.  

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ODAC will scrutinize data from the POLARIX trial. • Source: Shutterstock

The US Food and Drug Administration will seek external input on a new, first-line indication for Genentech, Inc.’s Polivy (polatuzumab vedotin-piiq), which currently holds accelerated approval for third-line treatment in diffuse large B-cell lymphoma (DLBCL).

The Oncologic Drugs Advisory Committee will meet on 9 March to discuss Polivy’s benefit-risk profile in patients with previously untreated DLBCL, according to a Federal Register notice scheduled for...

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