Epcoritamab-bysp and FDA’s Breakthrough Therapy Designation

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.

New Database: ClinicalKey

The MSK Library has added a new database resource, Elsevier’s ClinicalKey

ClinicalKey provides streamlined access to evidence-based information for clinicians, nurses, and healthcare professionals including quick answers at the point of care. It includes more than 1,000 medical books published by Elsevier including key texts used in medical education such as Gray’s Anatomy, Rang & Dale’s Pharmacology, Gunderson & Tepper’s Clinical Radiation Oncology, and Goldman’s Cecil Medicine. ClinicalKey also includes more than 650 journals (~100 being oncology-related), 3,000 drug monographs, 4,500 practice guidelines, and patient education information. Search and filter through these resources by source type, study type, specialty disciplines, and date.

Please note: Ebooks are readable online; in order to download a PDF you will need to create a personal account with Elsevier/ClinicalKey. To register for a new account on ClinicalKey, click the “Register” link in the top right while on the ClinicalKey platform. Enter your name and MSKCC email on the registration form.

If you have any questions about ClinicalKey, don’t hesitate to Ask Us!