FDA to Expedite Review of Novel Non-Hodgkin Lymphoma Drug

The Food and Drug Administration (FDA) granted a priority review for epcoritamab (DuoBody-CD3xCD20) for the treatment of patients with previously treated relapsed/refractory large B-cell lymphoma, — an aggressive subtype of non-Hodgkin lymphoma — according to Genmab, the manufacturer of the bispecific antibody.

In granting the priority review, the FDA is agreeing to expedite the review of the drug for potential approval. The agency plans on making a decision on epcoritamab’s approval by May 21, 2023, though that date is subject to change.

The priority review is based on findings from the phase 2 EPCORE NHL-1 trial, which included 157 patients with relapsed, progressive or refractory CD20-positive mature B-cell non-Hodgkin lymphoma.

Findings, which were presented at the Annual Meeting of the European Hematology Association in June, showed that 63% of patients experienced their disease shrink or disappear as a result of the treatment, including 39% who had a complete response, meaning that there were no traceable signs of cancer left.

For patients who did not previously undergo CAR-T cell therapy, 69% responded to treatment with epcortamab, including a 42% complete response rate. In patients who did undergo prior CAR-T cell therapy, 54% responded to the drug, and 34% experienced a complete response.

For those who had a complete response, 89% still had no evidence of cancer at a nine-month follow-up point.

The majority of side effects experienced by patients on the EPCORE NHL-1 trial occurred within the first 12 weeks of treatment and were resolved. Common side effects that occurred in 15% or more of patients given epcoritamab included: cytokine release syndrome (a condition where the body releases too many inflammatory molecules called cytokines; 49.7%); fever (23.6%); fatigue (22.9%); low levels of neutrophils (21.7%); diarrhea (20.4%); injection site reaction (19.7%); and anemia (17.8%).

Common severe side effects that occurred in 5% or more of patients were: neutropenia (14.6%); anemia (10.2%); decrease in neutrophils (6.4%); and decrease in thrombocytes, a type of platelet (5.7%).

“We are pleased that the (biologics license application) for epcoritamab has been accepted for priority review by the FDA, accelerating the pathway for approval and bringing us one step closer to potentially delivering a novel treatment option to relapsed and refractory (large B-cell lymphoma) patients who are in need of additional treatment options,” Jan van de Winkel, chief executive officer at Genmab, said in a company-issued press release.

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