FDA Declines BLA for Odronextamab for Non-Hodgkin Lymphoma

By Melissa Badamo - Last Updated: May 21, 2024

The US Food and Drug Administration (FDA) has declined approval of the bispecific antibody odronextamab for the treatment of non-Hodgkin lymphoma, according to a press release from Regeneron, the manufacturer of the drug.

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The Biologics License Application (BLA) for odronextamab for the treatment of relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DBCL) after two or more lines of systemic therapy was previously accepted for Priority Review by the FDA in September 2023.

The approval was declined due to the enrollment status of the confirmatory trials, the FDA wrote in response letters to the company.

The regulatory agency requires that the phase III trials include both dose-finding and confirmatory portions. While Regeneron has been enrolling patients in the dose-finding portions, the confirmatory portions “should be underway,” the company reported.

The complete response letters “did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling, or manufacturing,” according to the press release.

The CD20xCD3 bispecific antibody is being reviewed by the European Medicines Agency (EMA) and has been granted Orphan Drug Designation in the European Union.

“Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with [relapsed or refractory FL and DLBCL] as quickly as possible,” the company wrote in the press release.

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