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

 
• By Sue Sutter

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.

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An expanded indication for Polivy got a thumbs-up from ODAC. • Source: Shutterstock

Genentech, Inc.’s antibody drug conjugate Polivy (polatuzumab vedotin-piiq) has a favorable benefit-risk profile for front-line treatment of diffuse large B-cell lymphoma and should be considered an option, but not necessarily a replacement, for the current highly effective standard of care, US Food and Drug Administration advisory committee members said on 9 March.

Eleven of 13 members of the Oncologic Drugs Advisory Committee looked favorably upon the results from POLARIX, a Phase III trial in which polatuzumab, in combination with R-CHP (rituximab, cyclophosphamide,...

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