Regeneron Gets FDA Priority Review of Odronextamab in Follicular, Diffuse Large B-cell Lymphoma

By Colin Kellaher

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review of its application seeking approval of odronextamab for certain patients with the two most common subtypes of non-Hodgkin lymphoma.

The Tarrytown, N.Y., biotechnology company said the application covers odronextamab for adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma who have progressed after at least two prior systemic therapies.

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. Regeneron said the agency set a target action date of March 31, 2024, for its application.

Regeneron said an FDA green light would make odronextamab the first and only bispecific antibody approved in both follicular lymphoma and diffuse large B-cell lymphoma.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

September 29, 2023 08:56 ET (12:56 GMT)

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