Genmab's SBLA For Epcoritamab-bysp Granted Priority Review By FDA

(RTTNews) - Tuesday, Genmab A/S (GMAB) and AbbVie (ABBV) revealed that the FDA has given a Priority Review to the supplemental Biologics License Application or sBLA for Epcoritamab-bysp, a product of the collaboration between the two companies.

This is a T-cell engaging bispecific antibody administered subcutaneously, intended for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after undergoing two or more lines of systemic therapy.

The sBLA is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial, showing high overall and complete responses in R/R FL patients treated with epcoritamab.

The companies will divide commercial responsibilities in the U.S. and Japan, with AbbVie handling global commercialization.

The FDA has set a Prescription Drug User Fee Act or PDUFA target action date of June 28, 2024.