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FDA Grants Polatuzumab Vedotin Priority Review for DLBCL

Jason M. Broderick @jasoncology
Published: Tuesday, Feb 19, 2019

Dr. Sandra Horning

Sandra Horning, MD
The FDA has granted a priority review designation to polatuzumab vedotin for use in combination with bendamustine and rituximab (Rituxan; BR) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to Genentech (Roche), the manufacturer of the antibody-drug conjugate (ADC).

Genentech’s biologics license application (BLA) for polatuzumab vedotin is based on results from the phase Ib/II GO29365 study (NCT02257567), which were presented at the 2018 ASH Annual Meeting. In the study 40% of patients receiving the polatuzumab vedotin regimen reached a complete response (CR)—the primary endpoint of the study—compared with 18% of patients in the BR-alone arm (P = .026). Adding the ADC also showed an improvement in the exploratory endpoint of overall survival (OS), with a median OS of 12.4 months versus 4.7 months with BR alone (HR, 0.42; 95% CI, 0.24-0.75; P = .0023).

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