Regeneron nabs FDA priority review for lymphoma therapy
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Regeneron Pharmaceuticals (NASDAQ:REGN) announced Friday that the U.S. FDA accepted its Biologics License Application (BLA) for bispecific antibody odronextamab to review it on a priority basis for certain adults with lymphoma as a late-line option.
The BLA is aimed at securing U.S. marketing authorization for odronextamab to treat relapsed or refractory follicular lymphoma ((F.L.)) or R/R diffuse large B-cell lymphoma (DLBCL), the most common subtypes of B-cell non-Hodgkin lymphoma.

The FDA has set March 31, 2024, as the target action date to complete its review.
Regeneron (REGN) backs BLA with data from its ongoing Phase 1 (ELM-1) and pivotal Phase 2 (ELM-2) trials, which tested odronextamab in CD20+ B-cell malignancies and B-cell non-Hodgkin lymphoma, respectively.
Odronextamab is currently under the review in Europe for adults with R/R FL or R/R DLBCL who have received at least two systemic therapies previously, the same indication the company expects to clear in the U.S.



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