COPENHAGEN (dpa-AFX) - Genmab A/S(GMAB) said that the U.S. Food and Drug
Administration approved EPKINLY (epcoritamab-bysp) for the treatment of adults
with relapsed or refractory (R/R) follicular lymphoma or FL after two or more
lines of systemic therapy. The indication is approved under accelerated approval
based on response rate. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in a confirmatory clinical
trial(s).

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and
TEPKINLY in the EU) has received regulatory approval in certain lymphoma
indications in several territories. Epcoritamab is being co-developed by Genmab
and AbbVie as part of the companies' oncology collaboration. The companies will
share commercial responsibilities in the U.S. and Japan, with AbbVie responsible
for further global commercialization.

Genmab and AbbVie said they continue to evaluate the use of epcoritamab as a
monotherapy, and in combination, across lines of therapy in a range of
hematologic malignancies.

For More Such Health News, visit rttnews.com.



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX