Genentech Polivy’s Benefit-Risk Profile In First-Line Lymphoma Under Scrutiny

 
• By Sue Sutter

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.

First step
Genentech is seeking to make Polivy an option in the first-line setting. • Source: Shutterstock

Citing uncertainties in progression-free survival and overall survival data from the Phase III POLARIX trial, the US Food and Drug Administration is questioning whether the benefit-risk profile of Genentech, Inc.’s Polivy (polatuzumab vedotin-piiq) is favorable in the front-line, curative intent setting for certain types of non-Hodgkin lymphomas.

Genentech is seeking a first-line indication for use of polatuzumab, in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin and prednisone), for...

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