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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

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


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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemiaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
  
  	
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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 have a quick update on another recent FDA cancer therapeutic approval.

On October 1, 2021, the FDA approved brexucabtagene autoleucel (brand name Tecartus) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Efficacy was evaluated in ZUMA-3, a single-arm multicenter trial that evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor T-cell therapy, in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Patients received a single infusion of brexucabtagene autoleucel following completion of lymphodepleting chemotherapy.

The efficacy outcome measures used to support approval were complete response achieved within 3 months from infusion and duration of complete response. Of the 54 patients evaluated for efficacy, 28 achieved complete response within 3 months. With a median follow-up for responders of 7.1 months, the median duration of complete response was not reached; the duration of complete response was estimated to exceed 12 months for more than half the patients.

The prescribing information for brexucabtagene autoleucel has a boxed warning for cytokine release syndrome and neurologic toxicities. Cytokine release syndrome occurred in 92% of patients and neurologic toxicities occurred in 87%.

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/, key word search Approved Cellular and Gene Therapy Products. 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.

                                                                                  Content current as of:
      10/14/2021Resources 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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