FDA accepts supplemental Biologics license application for Polivy combination for people with previously untreated diffuse large B-cell lymphoma

The FDA is expected to make a decision on approval by 2 April 2023.

DLBCL is an aggressive blood cancer. 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.

The sBLA is based on results from the pivotal phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to 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 (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; p<0.02). safety outcomes were consistent with those seen in previous clinical trials, and the safety profile was comparable for polivy plus r-chp versus r-chop, including rates of grade 3-4 adverse events (aes; 57.7% versus 57.5%), serious aes (34.0% versus 30.6%), grade 5 aes (3.0% versus 2.3%), and aes leading to dose reduction (9.2% versus 13.0%).

Based on pivotal data from the POLARIX study, the European Commission approved Polivy in combination with R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL. Polivy is currently approved as a readily available, fixed-duration treatment option for relapsed or refractory (R/R) DLBCL in combination with bendamustine and Mabthera/Rituxan in more than 70 countries worldwide, including in the EU and in the United States.