The US Food and Drug Administration (FDA) has approved epcoritamab-bysp (EPKINLY) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The therapy received accelerated FDA approval based on the response rate observed in patients enrolled in the phase I/II EPCORE NHL-1 study. Genmab A/S, the manufacturer of the therapy, announced this approval in a press release. However, continued approval requires a confirmatory clinical trial to demonstrate and verify the clinical benefit.
Patients with relapsed or refractory follicular lymphoma encounter substantial treatment challenges, particularly in the third-line setting, according to Jeff Sharman, MD, Disease Chair of Hematology Research at the Sarah Cannon Research Institute in Eugene, Oregon.
“This approval and the durable responses observed in the follicular lymphoma cohort of the EPCORE NHL-1 clinical trial, which reflected a real-world patient population, including patients with difficult-to-treat follicular lymphoma, demonstrate the potential of EPKINLY for patients who face limited therapeutic options post-relapse,” Dr. Sharman said in the release.”
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