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Polivy FDA Approval History

Last updated by Judith Stewart, BPharm on July 1, 2019.

FDA Approved: Yes (First approved June 10, 2019)
Brand name: Polivy
Generic name: polatuzumab vedotin-piiq
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma

Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody–drug conjugate indicated in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.

  • Polivy works by binding to the CD79b protein expressed specifically in the majority of B-cells, then destroys those targeted B-cells through the delivery of an anti-cancer agent.
  • In clinical trials, patients treated with the Polivy and bendamustine/rituximab (BR) combination achieved a complete response rate of 40%, compared to 18% who were treated with BR alone.
  • Polivy is administered via intravenous infusion over 90 minutes every 21 days for six cycles, in combination with bendamustine and rituximab. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated.
  • Common adverse reactions (≥20%) include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.
  • The FDA granted accelerated approval for this indication. Continued approval for this indication may be contingent on further clinical trials to verify and describe Polivy’s clinical benefit.

Development timeline for Polivy

Jun 10, 2019Approval FDA Grants Genentech’s Polivy (polatuzumab vedotin-piiq) Accelerated Approval for Adults With Previously Treated Aggressive Lymphoma
Dec 10, 2017Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma

Further information

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