Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

Polivy FDA Approved for Patients with Relapsed or Refractory DLBCL

Web Exclusives - FDA Updates, Lymphoma

On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.

“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. “Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”

The FDA approval of polatuzumab was based on results from a phase 1b/2 clinical trial of 80 patients with relapsed or refractory DLBCL who received ≥1 previous treatments. Patients were randomized in a 1:1 ratio to polatuzumab plus bendamustine and rituximab or to bendamustine plus rituximab alone for six 21-day cycles.

The efficacy of the polatuzumab based combination regimen was based on complete response rate and duration of response, which was defined as the time the disease remained in remission. The results showed a complete response rate of 40% in the polatuzumab plus bendamustine and rituximab arm versus 18% in the bendamustine plus rituximab alone arm. Of the 25 patients who achieved a partial or a complete response with the polatuzumab-based regimen, 16 (64%) patients had a response lasting ≥6 months and 12 (48%) patients had a response lasting ≥12 months.

The most common (incidence ≥20%) adverse events in patients who received polatuzumab were neutropenia (49%), thrombocytopenia (49%), anemia (47%), peripheral neuropathy (40%), fatigue (40%), diarrhea (38%), pyrexia (33%), decreased appetite (27%), and pneumonia (22%).

Related Items
Tazverik Receives FDA Approval as First Treatment Specifically for Metastatic or Locally Advanced Epithelioid Sarcoma
Web Exclusives published on January 28, 2020 in FDA Updates, In the News, Sarcoma
FDA Grants Approval to Avapritinib for Patients with GIST
Web Exclusives published on January 13, 2020 in FDA Updates, Gastrointestinal Cancers, In the News, Rare Cancers
Recap of FDA Drug Approvals in 2019
Web Exclusives published on January 7, 2020 in FDA Updates, In the News
December 19, 2019 - FDA News & Updates
Web Exclusives published on December 17, 2019 in Drug Updates, FDA Updates
Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma
Web Exclusives published on December 11, 2019 in FDA Updates, In the News, Sarcoma
FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
Web Exclusives published on December 3, 2019 in Bladder Cancer, FDA Updates, Immunotherapy
Inrebic Receives FDA Approval for Adults with Myelofibrosis
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
Web Exclusives published on December 2, 2019 in FDA Updates
Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease
Web Exclusives published on November 25, 2019 in FDA Updates, In the News
Last modified: September 11, 2019