By Colin Kellaher

AbbVie and Genmab have won U.S. Food and Drug Administration priority review for their application seeking expanded approval of Epkinly in certain patients with hard-to-treat follicular lymphoma.

The companies on Tuesday said the application covers adults with relapsed or refractory follicular lymphoma after two or more lines of 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. The agency has set a target action date of June 28 for the application.

AbbVie and Genmab said Epkinly, if approved, would be the first and only subcutaneous bispecific antibody to treat adults with relapsed or refractory follicular lymphoma after two lines of prior therapy.

North Chicago, Ill., biopharmaceutical company AbbVie and Copenhagen biotechnology company Genmab are co-developing Epkinly under a 2020 collaboration.

The FDA and European regulators previously approved the drug for third-line treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.

Write to Colin Kellaher at

(END) Dow Jones Newswires

02-27-24 0827ET