Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee voted 11 to 2 in favor of Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma .
Diffuse large B-cell lymphoma or DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin's lymphoma in the United States.
The Advisory Committee 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 (sBLA) for Polivy in the indication by April 2, 2023.
Polivy in combination with bendamustine and Rituxan is currently approved in more than 80 countries worldwide for the treatment of adults with relapsed or refractory (R/R) DLBCL after one or more prior therapies, including in the U.S. under FDA accelerated approval.
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