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# Accelerated Approval for Genentech’s Polivy
- URL: https://www.fdaweb.com/accelerated-approval-for-genentechs-polivy/
- Published: 2019-06-10T12:00:00.000Z
- Updated: 2026-09-15T01:31:41.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144297

FDA has granted Genentech accelerated approval on a BLA for Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (also known as BR) for treating adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. “Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer,” FDA Oncology Center of Excellence acting director **Richard Pazdur** is quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-chemoimmunotherapy-regimen-patients-relapsed-or-refractory-diffuse-large-b-cell?ref=fdaweb.com) as saying. “This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs.”

Approval was based on data from a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. “At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone,” the agency says. “Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a \[duration of response\] DOR of at least six months and 12 (48%) had a DOR of at least 12 months.”

The most common side effects reported included low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.