AbbVie, Genmab Get FDA Priority Review of Epcoritamab in Large B-Cell Lymphoma

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 [e-mail]

(END) Dow Jones Newswires

11-21-22 0831ET