RHHBY - AbbVie/Genmab's Epkinly FDA Approval Is A Positive Step Analyst Says Additional Expansion Opportunities Underway | Benzinga
On Wednesday, the FDA approved Epkinly (epcoritamab-bysp) as the first and only T-cell-engaging bispecific antibody administered subcutaneously for adults with relapsed or refractory follicular lymphoma (r/r F) after two or more lines of prior therapy.
Epcoritamab is being co-developed by AbbVie Inc. (NYSE:ABBV) and Genmab A/S (NASDAQ:GMAB) as part of their oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
The indication is approved under the FDA’s Accelerated Approval program based on overall response rate (ORR) and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
About 15,000 people develop FL each year in the U.S., and it is considered incurable with current standard-of-care therapies.
FDA approval is based on Phase ...