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# Genmab BLA OK’d for Large B-cell Lymphoma
- URL: https://www.fdaweb.com/genmab-bla-okd-for-large-b-cell-lymphoma/
- Published: 2023-05-19T12:00:00.000Z
- Updated: 2026-09-14T18:33:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154497

FDA has granted Genmab an accelerated approval for its BLA for [Epkinly (epcoritamab-bysp) injection](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2023/761324s000lbl.pdf?ref=fdaweb.com) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B‑cell lymphoma after two or more lines of systemic therapy. DLBCLs are the most common type of non-Hodgkin lymphoma cancer and are associated with rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other tissues and organs, the [agency says](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell?utm%5Fmedium=email&utm%5Fsource=govdelivery). Epkinkly is intended to be administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity, it adds.

Approval was based on data from a study entitled [EPCORE NHL-1 (NCT03625037)](https://www.clinicaltrials.gov/ct2/show/NCT03625037?ref=fdaweb.com) that involved 148 patients with relapsed or refractory DLBCL that measured overall response rate (ORR). FDA says the study showed that the ORR was 61% with 38% of patients achieving complete responses. “With a median follow-up of 9.8 months among responders, the estimated median duration of response was 15.6 months,” it says.

FDA notes that the prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). “Among the 157 patients with relapsed or refractory large B-cell lymphoma who received Epkinly at the recommended dose, CRS occurred in 51% of patients, ICANS in 6%, and serious infections in 15%,” the agemcy says.