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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 Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma 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 May 19, 2023, the FDA granted accelerated approval to epcoritamab-bysp (brand name Epkinly) for relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

Epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, was evaluated in EPCORE NHL-1, an open-label, multi-cohort, multicenter, single-arm trial in patients with relapsed or refractory B-cell lymphoma. The efficacy population consisted of 148 patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.

The main efficacy outcome measure was overall response rate determined by Lugano 2014 criteria, as assessed by an Independent Review Committee. The overall response rate was 61% with 38% of patients achieving complete responses. With a median follow-up of 9.8 months among responders, the estimated median duration of response was 15.6 months.

The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome. Warnings and precautions include infections and cytopenias. Among the 157 patients with relapsed or refractory large B-cell lymphoma who received epcoritamab-bysp at the recommended dose, cytokine release syndrome occurred in 51% of patients, immune effector cell-associated neurotoxicity syndrome in 6%, and serious infections in 15%. For cytokine release syndrome, Grade 1 occurred in 37% of patients, Grade 2 in 17%, and Grade 3 in 2.5%. For immune effector cell-associated neurotoxicity syndrome, Grade 1 occurred in 4.5% of patients, Grade 2 in 1.3%, and Grade 5 in 0.6%.

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:
      06/21/2023Resources 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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