US - FDA Oncologic Drugs Advisory Committee (ODAC) meeting on March 9, 2023 Genentech’s Polivy (polatuzumab vedotin-piiq)
DA’s Oncologic Drugs Advisory Committee will cover topics related to confirmatory trials in oncology which is important to Gilead and Kite’s oncology portfolios and opt ins – specifically for the development of DLBCL products. Of interest to Regulatory Affairs and other departments, other learnings from this ODAC may include:
• insights into how the Oncology Center of Excellence is managing the accelerated approval pathway and confirmatory studies;
• consideration of PFS and OS in the context of a discussion on DLBCL.
The committee will discuss supplemental biologics license application (BLA) 761121/S-008, for Polivy (polatuzumab vedotin-piiq) for injection, submitted by Genentech. The proposed indication (use) for this product is in combination 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. The new proposed indication is based on the confirmatory study, POLARIX (Study GO39942). Based on the results of the POLARIX study, the committee will discuss the benefit-risk profile of POLIVY in patients with previously untreated DLBCL.
Meeting Materials
FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the live webcast will be available at: March 2023 Meeting
Relevant Resources: