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FDA Approves First Chemoimmunotherapy Regimen for DLBCL

June 11, 2019

The Food and Drug Administration (FDA) has approved a biologics license application (BLA) for Polivy (polatuzumab vedotin-piiq; Genentech Inc.) to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in combination with a rituximab product plus bendamustine in adult patients who received at least 2 prior therapies. This indication was granted accelerated approval based on complete response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Polivy is a novel humanized antibody-drug conjugate that targets CD79b, a protein expressed on the surface of B-cells. The FDA approval was based on data from the phase Ib/II G029365 trial, which evaluated Polivy in combination with rituximab and bendamustine versus rituximab and bendamustine alone in patients with relapsed/refractory DLBCL. The triplet therapy demonstrated a significant increase in positron emission tomography (PET)-based complete response rate, median progressive-free survival, and median overall survival compared with rituximab and bendamustine alone.

 

Food and Drug Administration (FDA). FDA Approves Polatuzumab Vedotin-piiq for Diffuse Large B-Cell Lymphoma [news release]. June 10, 2019. Available at: click here. Accessed June 11, 2019.