FDA Advisory Committee Supports Polatuzumab for Previously Untreated Diffuse Large B-cell Lymphoma

On April 2, 2023, the FDA will announce the approval status of Roche’s supplemental Biologics License Application for polatuzumab in the treatment of diffuse large B-cell lymphoma.

The FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 to support polatuzumab vedotin-piiq (Polivy) with rituximab (MabThera/Rituxan) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) as a treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Polatuzumab vedotin-piiq is a first-in-class antibody-drug conjugate that specifically targets CD76b, a protein expressed in the majority of B-cells.

The ODAC vote pertains to a supplemental Biologics License Application (sBLA) submitted by Roche based on results from the international, randomized, double-blind, and placebo-controlled phase 3 POLARIX study [NCT03274492], which found that polatuzumab and R-CHP reduced the risk of disease progression, relapse, or death by 27% compared to standard-of-care.

“Today’s committee decision to recognize the potential of this polatuzumab combination as a first-line treatment option is important since 4 in 10 people with diffuse large B-cell lymphoma relapse or do not respond to initial treatment,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development, in a press release.

The combination is now the first treatment in 2 decades to show a clinically meaningful improvement in the progression-free survival (PFS) of this patient population compared to standard-of-care. Prolonging survival rates without disease advancement could be a major step forward for this patient population, 40% of whom currently relapse following disease progression.

Investigators evaluated the polatuzumab combination versus standard of care (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for untreated DLBCL in POLARIX. The study included 879 patients randomized to receive polatuzumab with R-CHP or the polatuzumab placebo with R-CHOP combination. Polatuzumab and R-CHP decreased the risk of death more than standard-of-care, and the treatment had safety outcomes with consistent previous trials, according to the researchers.

Nearly 160,00 people are diagnosed with DLBCL each year. It is a common and aggressive form of non-Hodgkin lymphoma (NHL) that accounts for 1 in 3 cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory disease, for which there are limited treatment options and a high risk of mortality.

Polatuzumab binds to the CD79b protein expressed in many B-cells—an immune cell impacted by various types of NHL—and destroys these cancerous B-cells while minimizing damage to normal healthy cells. Polatuzumab which was developed using Seagen ADC technology, is being evaluated to treat various types of NHL.

The polatuzumab combination is approved in more than 60 countries, including the EU, UK, Japan, Canada, and China. Polatuzumab and R-CHP is now a preferred treatment for first-line DLCBL, according to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. The FDA will announce whether the sBLA for polatuzumab is approved by April 2, 2023.

“We believe the clinical benefit demonstrated in the POLARIX study may improve outcomes for many people with newly diagnosed DLBCL and look forward to continued collaboration with the FDA to make this treatment option available in the US,” Garraway said in the press release.


FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma. News release. Genentech. March 9, 2023. Accessed March 10, 2023. https://www.gene.com/media/press-releases/14984/2023-03-09/fda-advisory-committee-votes-in-favor-of

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