WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) Wednesday said that the U.S. Food and Drug Administration (FDA) has accepted resubmission of the Biologics License Application (BLA) for odronextamab to treat relapsed/refractory (R/R) follicular lymphoma (FL).
The regulator accepted BLA resubmission after Regeneron achieved the FDA-mandated enrollment target for the Phase 3 confirmatory trial. In the previous submission, the FDA had issued a complete response letter based on the enrollment status of the confirmatory trials.
The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials, which demonstrated an overall response rate of 80 percent, with 74 percent achieving a complete response.
Odronextamab is approved as Ordspono in the European Union for the treatment of R/R FL or diffuse large B-cell lymphoma (DLBCL).
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