FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
Regulatory approval news: On May 19, 2023, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) and high-grade B-cell lymphoma after ≥2 prior lines of systemic therapy. Approval was based on overall response rate and duration of response from the single-arm EPCORE NHL-1 trial. The label carries a Boxed Warning for CRS and ICANS.
FDA accelerated approval (May 19, 2023)
The US Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly; Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (including DLBCL arising from indolent lymphoma) and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Supporting evidence
Approval was based on EPCORE NHL-1 (NCT03625037), an open-label, multicenter, single-arm trial in relapsed/refractory B-cell lymphoma. The efficacy population included 148 patients with the approved histologies after ≥2 prior systemic regimens, including at least one anti-CD20 monoclonal antibody–containing therapy.
- Primary endpoint: overall response rate (ORR) per Lugano 2014, assessed by an Independent Review Committee.
- ORR: 61% (95% CI, 53–69); complete response rate: 38%.
- Among responders (median follow-up 9.8 months), estimated median duration of response (DOR) was 15.6 months (95% CI, 9.7–not reached).
Safety highlights from prescribing information
The label includes a Boxed Warning for serious or life-threatening CRS and life-threatening or fatal ICANS. In 157 treated patients at the recommended dose, CRS occurred in 51%, ICANS in 6%, and serious infections in 15%.
Dosing (label)
Epcoritamab-bysp is administered subcutaneously in 28-day cycles with step-up dosing in Cycle 1, then 48 mg on a decreasing-frequency schedule until disease progression or unacceptable toxicity.