March 9, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC) скачать в хорошем качестве

March 9, 2023 Meeting of the Oncologic Drugs Advisory Committee (ODAC)

The Committee will discuss supplemental biologics license application (sBLA) 761121/S-008, for POLIVY (polatuzumab vedotin-piiq) for injection, submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This product was approved under 21 CFR 601.41 (subpart E, accelerated approval regulations) for use in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, after at least two prior therapies. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a product after it receives accelerated approval. The new proposed indication is based on the confirmatory study, POLARIX (Study GO39942), conducted to fulfill post-marketing requirement 3630-1 detailed in the June 10, 2019, approval letter, available at https://www.accessdata.fda.gov/drugsa.... Based on the results of the POLARIX study, the committee will discuss the benefit-risk profile of POLIVY in patients with previously untreated DLBCL.