Genmab announces regulatory update for epcoritamab

Genmab announced regulatory updates from the FDA and European Medicines Agency, or EMA, for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The FDA has granted Breakthrough Therapy Designation, or BTD, to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory, or R/R, follicular lymphoma, or FL, after two or more lines of systemic therapy. BTD may expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies. Additionally, the EMA has validated a Type II variation application for epcoritamab for the same indication. EMA validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use, or CHMP. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.