AbbVie, Genmab Get FDA Priority Review of Epcoritamab in Large B-Cell Lymphoma
November 21 2022 - 8:46AM
Dow Jones News
By Colin Kellaher
AbbVie Inc. and Genmab A/S on Monday said the U.S. Food and Drug
Administration granted priority review to their application seeking
approval of epcoritamab in certain patients with large B-cell
lymphoma, an aggressive type of non-Hodgkin lymphoma.
The companies said the application covers epcoritamab for the
treatment of adults with relapsed/refractory large B-cell lymphoma
after two or more lines of systemic therapy.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period.
AbbVie and Genmab said the agency has set a target action date of
May 21, 2023, for the application.
North Chicago, Ill., biopharmaceutical company AbbVie and
Copenhagen biotechnology company Genmab are co-developing
epcoritamab under a 2020 collaboration.
The companies said epcoritamab, if approved, could become the
first subcutaneous bispecific antibody available for the treatment
of large B-cell lymphoma.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 21, 2022 08:31 ET (13:31 GMT)
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