FDA Accepts Roche’s sBLA for Polivy in Diffuse Large B-Cell Lymphoma

The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).

The sBLA is supported by results from a phase 3 clinical trial that showed clinically meaningful improvements in progression-free survival compared with the standard of care treatment of Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone.

“We are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” said Levi Garraway, Roche’s chief medical officer.

The FDA is expected to make a decision on the sBLA by April 2, 2023.