Officials with the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy) in combination with bendamustine plus rituximab (Rituxan) (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least 2 prior therapies, according to a press release.
With approximately 25,000 new cases expected to be diagnosed in 2019, DLBCL is the most common form of non-Hodgkin lymphoma. However, the disease can become more difficult to treat upon multiple relapses or no response to treatment, and as many as 40% of patients will relapse.
Polatuzumab vedotin-piiq is a first-in-class antibody-drug conjugate that specifically targets CD76b, a protein expressed in the majority of B-cells, according to Genentech.
Accelerated approval of the treatment was based on data from the phase 1b/2 GO29365 study. The trial included patients with relapsed or refractory DLBCL who are ineligible for a hematopoietic stem cell transplant.
According to Genentech, this is the first randomized clinical trial to demonstrate higher response rates over BR, which is commonly used in this patient population.
In the study, 40% of patients treated with polatuzumab vedotin-piiq plus BR achieved a complete response (n=16/40; 95% CI: 25-27) compared with 18% with BR alone (n=7/40; 95% CI: 7-33).
Other key findings included:
This article was originally published on Specialty Pharmacy Times.