On Tuesday, the pharmaceutical companies Genmab A/S and AbbVie announced that the Food and Drug Administration (FDA) has assigned a Priority Review status to the supplemental Biologics License Application (sBLA) for the drug, Epcoritamab-bysp. This medicine, developed collaboratively by both firms, is a bispecific antibody that stimulates T-cell activity. It is delivered via subcutaneous injection and is designed to treat adults who have relapsed or refractory follicular lymphoma and have previously tried at least two systemic therapy lines.
Evidence from an EPCORE NHL-1 Phase 1/2 clinical trial, which demonstrated high overall and complete responses in patients with relapsed or refractory follicular lymphoma, supports the sBLA.
Genmab and AbbVie agreed to share commercial responsibilities for the drug in the U.S. and Japan, with AbbVie undertaking the task of global commercialization. The FDA has set June 28, 2024, as the target action date under the Prescription Drug User Fee Act (PDUFA).
