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

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, multicenter single-arm trial that included 127 patients with relapsed or refractory FL after at least two