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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapyResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
  
  	
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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 another quick update on a recent FDA cancer therapeutic approval.

On March 5, 2021, the FDA granted approval to axicabtagene ciloleucel (brand name Yescarta) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Approval in follicular lymphoma was based on ZUMA-5 a single-arm, open-label, multicenter trial that evaluated axicabtagene ciloleucel, a CD19-directed CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. Following lymphodepleting chemotherapy, axicabtagene ciloleucel was administered as a single intravenous infusion.

The main efficacy measures were objective response rate and duration of response as determined by an independent review committee. Among 81 patients in the primary efficacy analysis, the objective response rate was 91% with a complete remission rate of 60% and a median time-to-response of 1 month. The median duration of response was not reached, and the 1-year rate of continued remission was 76.2%. For all leukapheresed patients in this trial, the objective response rate was 89% with a complete remission rate of 62%.

The prescribing information for axicabtagene ciloleucel has a boxed warning for cytokine release syndrome and neurologic toxicities. In studies of axicabtagene ciloleucel among all patients with non-Hodgkin’s lymphoma, cytokine release syndrome occurred in 88% of patients, 10% having Grade 3 or higher and neurologic toxicities occurred in 81%, with 26% having Grade 3 or higher.

Full prescribing information for this approval can be found on the web at www.fda.gov, with key word search “Approved Cellular and Gene Therapy Products”.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System 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 into the DISCO Burst Edition.

                                                                                  Content current as of:
      03/22/2021Resources 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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