Primary Indication from Trials
Polivy (polatuzumab vedotin-piiq), an antibody-drug conjugate, targets CD79b on B-cells. Its pivotal approval came from the Phase III POLARIX trial, evaluating it combined with Rituxan (rituximab), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma.[1][2]
Other Cancer Types Tested
Early development and trials explored Polivy in additional B-cell malignancies:
- Relapsed or refractory DLBCL (Phase II ROMULUS and Phase Ib/II trials).[2]
- Follicular lymphoma (Phase II trial with Rituxan and bendamustine).[2]
- Relapsed or refractory follicular lymphoma (Phase II trial).[2]
No approvals or large-scale trials targeted solid tumors or non-B-cell cancers.
How Trials Led to Approvals
The FDA granted accelerated approval in 2019 for relapsed/refractory DLBCL (with bendamustine and Rituxan), converted to full approval in 2023 based on ROMULUS data. Full approval for first-line DLBCL followed the 2023 POLARIX results, showing improved progression-free survival.[1][2] EU approvals mirror this for DLBCL.
Ongoing or Exploratory Trials
Current trials (e.g., NCT03671018, NCT03677141) test Polivy in earlier DLBCL lines, high-grade B-cell lymphoma, and combinations like with lenalidomide. Pediatric trials (NCT03677141) target relapsed/refractory B-cell lymphomas.[2]
[1]: FDA Approval Summary for Polivy
[2]: ClinicalTrials.gov Search for Polivy
[3]: DrugPatentWatch.com - Polivy Patents