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The FDA to epcoritamab (Epkinly) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B‑cell lymphoma on Friday.

The approval allows the drug's use after two or more lines of systemic therapy in patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma.

"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," said Tycel Phillips, MD, of City of Hope in Duarte, California, from drugmaker AbbVie.

"Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population," he added. "With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."

The approval was based on results from the , which included 148 patients. Of these patients, 89% were diagnosed with DLBCL NOS, including 28% with DLBCL transformed from indolent lymphoma, and 14% with high-grade B-cell lymphoma.

The overall response rate -- the primary outcome -- was 61% (95% CI 53-69), with 38% of patients achieving complete response. With a median follow-up of 9.8 months, the estimated median duration of response was 15.6 months (95% CI 9.7 to not reached).

The median number of prior therapies was 3 (range 2-11), with 29% of patients receiving two prior therapies, 32% receiving three prior therapies, and 39% receiving four or more prior therapies. Eighteen percent had prior autologous hematopoietic stem cell transplantation, and 39% had prior chimeric antigen receptor (CAR) T-cell therapy. Most patients (82%) had disease refractory to last therapy, and 29% were refractory to CAR T-cell therapy.

Epcoritamab is injected subcutaneously in 28-day cycles until disease progression or unacceptable toxicity.

for the drug has a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity.

Among patients with relapsed or refractory large B-cell lymphoma who received epcoritamab at the recommended dose, CRS occurred in 51% of patients, ICANS occurred in 6%, and serious infections occurred in 15%.

The most common adverse reactions with epcoritamab included CRS, fatigue, musculoskeletal pain, injection site reactions, fever, abdominal pain, nausea, and diarrhea. The most common grade 3-4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.

A phase III randomized trial to confirm epcoritamab's clinical benefit is ongoing and is evaluating the drug versus standard-of-care chemoimmunotherapy in patients with relapsed or refractory DLBCL. The primary study outcome is overall survival.

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