Genmab (GMAB) has released an update.
Genmab A/S announced the FDA approval of EPKINLY (epcoritamab-bysp) for treating adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. EPKINLY, a T-cell engaging bispecific antibody administered subcutaneously, is the first of its kind in the U.S. for this condition and offers a new, potentially durable treatment option for patients facing limited therapeutic alternatives. The approval is based on the EPCORE NHL-1 clinical trial results, which showed a high overall response and complete response rates, with over half of the responding patients maintaining their response over time.
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