Accelerated approvals of Epkinly, Augtyro, Krazati among FDA’s June label expansions
The month also brought conversions to full approval for Retevmo and Sirturo
FDA’s Center for Drug Evaluation and Research approved at least 10 supplemental applications last month that sought approvals for new indications, including three accelerated approvals. The agency also converted two accelerated approvals to full approvals.
The agency granted accelerated approval to Epkinly epcoritamab to treat follicular lymphoma, after two lines of therapy. The decision was based on the Phase I/II EPCORE NHL-1 trial, in which Epkinly led to an objective response rate (ORR) of 82% and a complete response (CR) rate of 63%, with a median time to CR of 1.5 months. Genmab A/S (CSE:GMAB; NASDAQ:GMAB) and AbbVie Inc. (NYSE:ABBV) co-developed the CD20xCD3 bispecific antibody, which first received approval last year for diffuse large B cell lymphoma and high-grade B cell lymphoma. ...