The Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq; Genentech), in combination with bendamustine plus rituximab (BR), for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least 2 prior therapies.
The approval of Polivy, a CD79b-directed antibody–drug conjugate, was based on data from an open-label phase 1b/2 study (GO29365) that included 80 patients with R/R DLBCL after at least 1 prior regimen. Patients were randomized 1:1 to receive either Polivy with BR or BR alone for six 21-day cycles. Efficacy was based on complete response rate and duration of response (DOR).
Results showed a 40% complete response rate for Polivy plus BR compared with 18% for BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least 6 months and 12 (48%) had a DOR of at least 12 months. Additionally, 12 patients (48%) treated with Polivy plus BR had a DOR ≥1 year as compared with 2 patients (20%) treated with BR alone.
Regarding safety, the most common treatment-related adverse reactions included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite, and pneumonia.
“Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”
Polivy will be supplied as a preservative-free lyophilized powder in 140mg single-dose vials for intravenous infusion.
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