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.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly
See Insiders’ Hot Stocks on TipRanks >>
Read More on RHHBY:
- FDA Advisory Committee votes in favour of the clinical benefit of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma
- FDA Oncologic Drugs Advisory Committee to hold a virtual meeting
- Roche announces FDA approval of VENTANA PD-L1 Assay
- Roche expands collaboration with CDC to strengthen laboratory capabilities
- Societe Generale upgrades Roche to Buy, says ‘enough is enough’