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JUNE 27, 2024

FDA Grants Accelerated Approval to Epkinly for Relapsed or Refractory Follicular Lymphoma


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab U.S.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Efficacy and safety were evaluated in EPCORE NHL-1 (Study GCT3013-01; ClinicalTrials.gov. Identifier: NCT03625037), an open-label, multi-cohort,