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Genentech : FDA Accepts SBLA For Polivy Combination For Aggressive Blood Cancer

The U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma or DLBCL, Genentech, a member of the Roche Group (RHHBY), said in a statement.

The application is based on pivotal data from the Phase III POLARIX study showing Polivy plus R-CHP significantly reduced the risk of disease progression, relapse or death with comparable safety versus the standard of care, R-CHOP.

The FDA is expected to make a decision on approval by April 2, 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 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 Rituxan/Mabthera in more than 70 countries worldwide, including in the United States and in the EU.

Genentech said it continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with the company's CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.

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