Regeneron’s CD20xCD3 therapy among new recommendations by EMA’s CHMP

EMA’s CHMP recommended approval of seven new medicines, including Regeneron cancer bispecific antibody Ordspono odronextamab, and label expansions for 10 approved therapies in the month of June. 

The committee’s positive opinion on Ordspono from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is for use in follicular lymphoma and diffuse large B cell lymphoma after two or more lines of systemic therapy. In March, the FDA issued a complete response letters to the BLAs seeking accelerated approval of the CD20xCD3 antibody, based on the lack of an enrolled confirmatory trial. In December 2022, Congress gave FDA the power to refuse to approve an application for accelerated approval if a trial to confirm clinical benefit was not under way...