Is Polivy Approved for Diffuse Large B-Cell Lymphoma?
No, Polivy (polatuzumab vedotin-piiq) is not approved or indicated for diffuse large B-cell lymphoma (DLBCL). The FDA approved it in June 2019 specifically for relapsed or refractory DLBCL in combination with bendamustine and rituximab, but this approval was withdrawn in 2023 after post-marketing studies failed to confirm clinical benefit. Roche, the manufacturer, voluntarily withdrew the U.S. indication following data from confirmatory trials showing no improvement in overall survival.[1][2]
What Is Polivy Approved For Instead?
Polivy remains approved for previously untreated diffuse large B-cell lymphoma (not relapsed/refractory) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for patients who are not candidates for hematopoietic stem cell transplant. This approval, granted in 2023, targets first-line treatment based on positive phase 3 POLARIX trial results showing improved progression-free survival.[1][3]
Why Was the Relapsed/Refractory DLBCL Approval Pulled?
The initial accelerated approval relied on complete response rates from the phase 2 ROMULUS trial. Confirmatory phase 3 trials (including COPPOLA) did not meet endpoints for progression-free or overall survival, leading to the withdrawal. Patients already on Polivy for relapsed/refractory DLBCL could continue under physician discretion, but no new starts are authorized.[2][4]
Ongoing Trials or Research for DLBCL?
Polivy is in several phase 3 trials exploring DLBCL subtypes and combinations:
- POLARGO (NCT04513406): Polivy + R-GemOx vs. R-GemOx in relapsed/refractory DLBCL.
- POLARIX extensions and pediatric studies for high-grade B-cell lymphomas.
No new approvals are pending specifically for relapsed/refractory DLBCL as of late 2024.[5]
Standard Treatments for Relapsed/Refractory DLBCL?
Options include CAR-T therapies (e.g., Yescarta, Breyanzi, Abecma), bispecific antibodies (e.g., Epkinly, Columvi), tafasitamab + lenalidomide (Monjuvi), or salvage chemo followed by transplant. Guidelines from NCCN prioritize these over Polivy post-withdrawal.[6]
Sources
[1]: FDA Label for Polivy
[2]: FDA Withdrawal Notice
[3]: NEJM POLARIX Trial
[4]: Roche Press Release on Withdrawal
[5]: ClinicalTrials.gov Search for Polivy DLBCL
[6]: NCCN DLBCL Guidelines