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FDA AdCom votes in favor of Genentech’s Polivy combination in DLBCL

Genentech, a member of the Roche Group, announced that the FDA Oncologic Drugs Advisory Committee, or ODAC, voted 11 to 2 in favor of Polivy, or polatuzumab vedotin-piiq, in combination with Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma, or DLBCL. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA is expected to make a final decision on its review of the supplemental Biologics License Application for Polivy in this indication by April 2, 2023.

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