FDA Accepts Polivy sBLA for Aggressive Blood Cancer

The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.

The FDA has accepted Genentech’s supplemental biologics license application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with monoclonal antibody Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by April 2, 2023.

DLBCL is a cancer that starts in white blood cells, specifically those that make antibodies to fight infections. It is an aggressive disease, with a five-year survival of 64.6%, according to the National Cancer Institute. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment and the majority of those who require subsequent lines of therapy have poor outcomes.

Polivy is a first-in-class antibody-drug that targets CD79b, which is expressed on the surface of malignant B cells, the immune cells impacted in some types of non-Hodgkin’s lymphoma (NHL). The FDA approved Polivy in June 2019 to be used in combination with the chemotherapy drug bendamustine and rituximab for adult patients with relapsed or refractory diffuse large B-cell lymphoma. Currently, Polivy is used off label with R-CHP combination.

The application is based on the results from the pivotal phase 3 POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared with the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).

The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months. Safety outcomes were consistent with those seen in previous clinical trials.

“The POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,” Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development, said in a press release.

Genentech continues to study Polivy in ongoing studies investigating combinations with mosunetuzumab and glofitama, two bispecific antibodies also being developed by Genentech. Both products are designed to target CD20 on the surface of B cells and CD3 on the surface of T cells.

Polivy is also being studied with Venclexta (venetoclax), which is being developed by AbbVie and Genentech, and with Rituxan in combination with gemcitabine and oxaliplatin in the phase 3 POLARGO study.