Regeneron Pharmaceuticals is taking another shot at US Food and Drug Administration (FDA) accelerated approval for odronextamab in relapsed/refractory follicular lymphoma (r/r FL), with the agency now set to review its resubmitted application and issue a decision by 30 July 2025.
The initial application was rejected in March 2024 due to concerns about the enrolment status of Regeneron’s Phase III confirmatory trial, OLYMPIA-1 (NCT06091254). At the time, the FDA cited the study’s progress as the reason for issuing a complete response letter (CRL), marking the first time the agency had used this rationale to delay a biologics licence application (BLA).
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While the company had initiated enrolment in the dose-finding portion of the trial, the FDA said that the confirmatory portion should be at the same stage to classify for the accelerated approval pathway. The agency added timelines should be laid out and agreed upon before any resubmission from the biotech.
In response to uncertainty, the FDA recently clarified its expectations for determining whether a confirmatory trial is underway draft guidance published in January 2025. The agency outlined requirements such as studies having an established timeline reflecting “diligent and timely” progress, demonstrating active enrolment to provide “sufficient assurance” of completion, and has already begun enrolling patients.
Regeneron says its resubmission follows the achievement of an FDA-mandated enrolment target for OLYMPIA-1, which it described as the only issue identified in the CRL. According to GlobalData’s Clinical Trials Database, the trial is set to enrol 478 patients.
The BLA resubmission is supported by data from the Phase I ELM-1 (NCT02290951) and Phase II ELM-2 (NCT03888105) trials, which demonstrated an 80% overall response rate in patients with r/r FL, with 74% achieving a complete response. Serious adverse events (SAEs) were reported in 67% of patients, including cytokine release syndrome and pneumonia in less than 10% of participants.
If approved, odronextamab would join a few CD20×CD3 bispecific antibodies available in the US. This includes AbbVie and Genmab’s Epkinly (epcoritamab), which is forecast to pull in $1.9bn in sales in 2030, as per GlobalData’s Pharma Intelligence Center.
Odronextamab, which is designed to bridge CD20-expressing cancer cells with CD3-positive T cells to trigger an immune response, has already been approved by the European Commission (EC) under the brand name Ordspono for r/r FL and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. GlobalData projects odronextamab to generate global sales of $560m in 2030.
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