Danish biotech Genmab announced this week that the FDA had accepted its Biologics License Application and granted Priority Review for its B-cell lymphoma bispecific antibody, co-developed with AbbVie.
The BLA was supported by the investigational phase 2 EPCORE trial, which evaluated epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). Trial results, shared in June of this year, revealed that the drug demonstrated clinically meaningful efficacy in challenging-to-treat, highly refractory LBCL patients, including patients previously treated with chimeric antigen receptor (CAR) T-cell therapy.
Epcoritamab is the result of a broad oncology collaboration between Genmab and AbbVie that started in 2020, in which AbbVie paid Genmab $750 million with potential milestone payments totaling 2.15 billion. Since then, the two have partnered to combine Genmab’s DuoBody technology and AbbVie’s payload and ADC technology to select and develop up to four additional differentiated next-generation antibody-based product candidates.
Epcoritamab’s Prescription Drug User Fee Act (PDUFA) date is now May 21, 2023. Roche’s rival immunotherapy, mosunetuzumab, was granted Priority Review back in July and has a decision date of December 29, 2022.