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The Food and Drug Administration (FDA) Oncology Drugs Advisory Committee (ODAC) voted 11 to 2 in favor of polatuzumab vedotin-piiq (Polivy®) in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
At the advisory committee meeting, the panel reviewed data from the randomized, double-blind, placebo-controlled phase 3 POLARIX trial (ClinicalTrials.gov Identifier: NCT03274492), which was intended to fulfill a postmarketing requirement under accelerated approval regulations. Polatuzumab vedotin-piiq, a CD79b-directed antibody-drug conjugate, was granted accelerated approval in June 2019 for use in combination with bendamustine plus rituximab, for the treatment of adults with relapsed or refractory DLBCL who had received at least 2 prior therapies.
The POLARIX trial included 879 adults with previously untreated DLBCL. Results showed a 27% reduction in the risk of disease progression, relapse or death with polatuzumab vedotin plus R-CHP vs rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) (hazard ratio, 0.73; 95% CI, 0.57-0.95; P <.02). The safety profile of polatuzumab vedotin plus R-CHP was comparable to R-CHOP.
Findings from the final prespecified analysis (median follow-up of 39.7 months) did not demonstrate an improvement in overall survival with polatuzumab vedotin (hazard ratio, 0.94; 95% CI, 0.67-1.33). The panel also noted that while other efficacy endpoints (eg, event free survival, complete response rate, disease-free survival and duration) were supportive, they had limitations.
A decision on the application is expected by April 2, 2023. Although not bound by the panel’s recommendations, the FDA will take them into consideration when making final decisions on approval.
References
- FDA advisory committee votes in favor of the clinical benefit of Genentech’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma. News release. Genentech. March 9, 2023. Accessed March 10, 2023. https://www.businesswire.com/news/home/20230309005120/en/FDA-Advisory-Committee-Votes-in-Favor-of-the-Clinical-Benefit-of-Genentechs-Polivy-Combination-for-People-With-Previously-Untreated-Diffuse-Large-B-Cell-Lymphoma.
- Meeting of the Oncologic Drugs Advisory Committee- combined FDA and Genentech briefing document. March 9, 2023. Accessed March 10, 2023. https://www.fda.gov/media/165961/download.
