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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
  
  	
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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On April 19, 2023, the FDA approved polatuzumab vedotin-piiq, brand name Polivy, with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.

Approval was based on POLARIX, a randomized, double-blind, placebo-controlled trial in 879 patients with previously untreated large B-cell lymphoma and an International Prognostic Index score of 2-5. The trial evaluated the superiority of substituting polatuzumab vedotin for vincristine in the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone regimen. Patients were randomized 1 to 1 to receive either polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone for six 21-day cycles, followed by two additional cycles of rituximab alone in both arms. The main diagnoses were de novo diffuse large B-cell lymphoma, not otherwise specified and high-grade B-cell lymphoma.

Efficacy was based on investigator-assessed progression-free survival. Progression-free survival was statistically significantly longer in the experimental arm, with a hazard ratio of 0.73. This arm also had a statistically significant improvement in modified event-free survival. No significant difference in complete response rate or overall survival was observed.

The most common adverse reactions in the experimental arm occurring in more than 20% of patients, excluding laboratory abnormalities, were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. Grade 3 to 4 laboratory abnormalities occurring in more than 10% of patients were lymphopenia, neutropenia, hyperuricemia, and anemia. Peripheral neuropathy developed or worsened in 53% of patients, with resolution in 58% after a median of 4 months. Serious adverse reactions occurred in 34% of patients, including febrile neutropenia and pneumonia.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning in to the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      06/07/2023Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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