Nov. 18 at 3:28 PM
$GMAB $30.05
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UPDATE:
On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).
Full prescribing information for Epkinly will be posted on Drugs@FDA.
Approval of epcoritamab-bysp with lenalidomide and rituximab (R2) was based on EPCORE FL-1 (Study M20-638; NCT05409066), a randomized, open-label trial that enrolled 488 patients with relapsed or refractory FL. Patients were randomized (1:1) to receive epcoritamab-bysp plus R2 or R2 alone. Patients had a median of 1 prior line of systemic therapy (range: 1 to 7); 24% and17% had two and three or more prior lines, respectively.
Efficacy was established based on progression free survival (PFS) and overall response rate (ORR) as assessed by an independent review committee (IRC) using Lugano 2014 Criteria. The study demonstrated superiority of PFS and ORR in the epcoritamab-bysp arm. The PFS hazard ratio was 0.21 (95% CI: 0.13, 0.33; p-value <0.0001). The median PFS was not reached (NR) (95% CI: 21.9 months, NR) in the epcoritamab-bysp arm and was 11.2 months (95% CI: 10.5, NR) in the control arm. The ORR was 89% (95% CI: 84, 93) in the epcoritamab-bysp arm and 74% (95% CI: 68, 79) in the control arm.
The prescribing information includes boxed warnings for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), as well as warnings and precautions for infections and cytopenias. Serious adverse reactions occurred in 51% of the patients in the epcoritamab-bysp arm, including serious infections in 28%. CRS occurred in 24% of patients, including serious CRS in 12%. ICANS occurred in 0.8%.
The recommended regimen for epcoritamab-bysp in combination with R2 consists of epcoritamab-bysp administered subcutaneously for up to twelve 28-day cycles, with lenalidomide on Days 1-21 of each cycle and rituximab for 5 cycles. The recommended epcoritamab-bysp dosage is a 3 step-up dosage schedule in Cycle 1 (0.16 mg on Day 1, 0.8 mg on Day 8, 3 mg on Day 15, and 48 mg on Day 22), followed by weekly dosing of 48 mg in Cycle 2 and 3, then every 4-week dosing of 48 mg in Cycles 4 to 12.
This review was conducted as a Summary Review and used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted breakthrough designation, priority review, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
