FDA Approval Insights: Epcoritamab Plus Rituximab/Lenalidomide for Relapsed/Refractory Follicular Lymphoma: With Lorenzo Falchi, MD

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, the discussion features Lorenzo Falchi, MD, a medical oncologist/hematologist and assistant attending physician in the Lymphoma Service at Memorial Sloan Kettering Cancer Center in New York, New York, who provided clinical and regulatory perspectives on the FDA approval of epcoritamab-bysp (Epkinly) in combination with rituximab (Rituxan) and lenalidomide (Revlimid) for relapsed/refractory follicular lymphoma after at least 2 prior lines of therapy. The approval was supported by primary results from the randomized phase 3 EPCORE FL-1 trial (NCT05409066).

In this exclusive interview, Dr Falchi discussed why this approval is clinically meaningful—establishing a chemotherapy-free triplet that significantly improves outcomes over the long-standing rituximab/lenalidomide backbone in the second-line setting and beyond—and reviewed practical considerations that inform real-world uptake of the regimen, including outpatient administration feasibility and mitigation of bispecific antibody–associated toxicities, such as cytokine release syndrome. He also placed EPCORE FL-1 in the broader epcoritamab development program, referencing supportive experience with the phase 1/2 EPCORE NHL-2 trial (NCT04663347) and ongoing efforts to move bispecific antibody–based regimens earlier in the treatment paradigm through the phase 3 EPCORE FL-2 trial (NCT06191744).

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