Epkinly (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

June 27, 2024

U.S. FDA approves Epkinly (epcoritamab-bysp) for relapsed or refractory follicular lymphoma after two or more lines of therapy, making it the first subcutaneous T-cell engaging bispecific antibody for this patient population. Approval based on response rate; continued approval contingent on clinical benefit verification in confirmatory trials.

Related Clinical Trials

A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

Highlighted Terms

NCT06191744 NCT04628494 Genmab A/S The Leukemia & Lymphoma Society Sarah Cannon Research Institute (SCRI)U.S. Food and Drug Administration NCT05578976 epcoritamab-bysp Epkinly Follicular Lymphoma National Comprehensive Cancer Network NCT05409066

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Epkinly (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)