FDA Approves Genentech’s Medicine For People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma
April 19th, 2023
On April 19, 2023, the FDA approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) of two or greater.
News in brief
- Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma.
- Polivy is a first-in-class anti-CD79b antibody-drug conjugate. The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL).
- The approval is based on positive results from the pivotal POLARIX trial, which demonstrated statistically significant and clinically meaningful improvement in progression-free survival compared to the current standard of care.
- DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin lymphoma in the United States. Approximately 31,000 people in the U.S. are projected to be diagnosed with DLBCL in 2023.
“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma. Today’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”