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The FDA just granted Breakthrough Therapy Designation to Epcoritamab-bysp (brand name is Epkinly) for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL).
The decision to grant BTD was supported by the results from the clinical trial NCT03625037, “First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1).
Obtaining Breakthrough Therapy Designation helps facilitate the development of new drugs and treatment options for patients.
Based on the same clinical trial, the FDA approved epcoritamab for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma in May 2023. In the podcast “Oncology Nursing News: The Vitals” Laura Zitella, a nurse at UCSF Health, discusses the newly approved epcoritamab-bysp for DLBCL.
The estimated study completion date of the clinical trial NCT03625037 is April 2024.