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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 Breyanzi (lisocabtagene maraleucel) for second-line treatment of large B-cell lymphomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Breyanzi (lisocabtagene maraleucel) for second-line treatment of large 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 another quick update on a recent FDA cancer drug approval. On June 24, 2022, the FDA approved lisocabtagene maraleucel (brand name Breyanzi) for adult patients with large B-cell lymphoma who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first -line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

Efficacy was evaluated in TRANSFORM, a randomized, open-label, multicenter trial in adult patients with primary refractory large B-cell lymphoma or relapse within 12 months of achieving complete response to first-line therapy. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous hematopoietic stem cell transplantation. A total of 184 patients were randomized 1:1 to receive a single infusion of lisocabtagene maraleucel following fludarabine and cyclophosphamide lymphodepleting chemotherapy or to receive second-line standard therapy, consisting of three cycles of chemoimmunotherapy followed by high-dose therapy and autologous hematopoietic stem cell transplantation in patients who attained complete response or partial response.

The primary efficacy measure was event-free survival as determined by an independent review committee. Event-free survival was significantly longer in the lisocabtagene maraleucel arm with a hazard ratio of 0.34. The estimated 1-year event-free survival was 45% in the lisocabtagene maraleucel arm and 24% in the standard therapy arm. The estimated median event-free survival was 10.1 months and 2.3 months, respectively. Of patients randomized to receive standard therapy, 47% received autologous HSCT as planned, with lack of response to chemotherapy being the most common reason for not receiving hematopoietic stem cell transplantation. The independent review committee-assessed progression-free survival was also significantly longer in the lisocabtagene maraleucel arm with a hazard ratio of 0.41.

Efficacy was also evaluated in PILOT, a single-arm, open-label, multicenter trial in transplant-ineligible patients with relapsed or refractory large B-cell lymphoma after one line of chemoimmunotherapy. The study enrolled patients who were ineligible for high-dose therapy and hematopoietic stem cell transplantation due to organ function or age, but who had adequate organ function for CAR-T cell therapy. Efficacy was based on complete response rate and duration of response as determined by an independent review committee. Of 74 patients who underwent leukapheresis, 61 received lisocabtagene maraleucel of whom 54% achieved complete response. The median duration of response was not reached in patients who achieved complete response and 2.1 months in patients with a best response of partial response. Among all leukapheresed patients, the complete response rate was 46%.

FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening cytokine release syndrome and neurologic toxicities. In studies of lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma, cytokine release syndrome occurred in 45% of patients, and neurologic toxicities occurred in 27%. Serious adverse reactions occurred in 33% to 38% of patients.

Full prescribing information for these approvals can be found 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 to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      07/21/2022Resources 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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