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

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

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

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

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)

Highlighted Terms

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

Related News

drugs.com

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