TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) regarding its Biologics License Application (BLA) for the experimental cancer drug odronextamab.
The CRLs, which address the drug's use for relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), cited the need for further progress in confirmatory trial enrollment as the sole issue preventing approval.
The FDA's response did not raise concerns about the clinical efficacy or safety of odronextamab, nor did it question the trial design, labeling, or manufacturing processes.
The agency's requirement pertains to the enrollment status of the confirmatory trials within the OLYMPIA program, a comprehensive series of Phase 3 trials aimed at establishing odronextamab as a treatment for various B-cell non-Hodgkin lymphoma subtypes.
Regeneron has already initiated patient enrollment in the dose-finding portion of these trials. However, the CRLs specify that the confirmatory portions must be actively underway and that timelines for completion should be established before the BLA can be resubmitted.
The company has expressed its commitment to working closely with the FDA and clinical trial investigators to expedite the availability of odronextamab for patients with R/R FL and R/R DLBCL. Further updates on the progress of enrollment and regulatory timelines are expected to be released later in the year.
While the FDA review process is ongoing, the European Medicines Agency (EMA) is also currently evaluating odronextamab for the treatment of R/R DLBCL and R/R FL. The drug has been granted Orphan Drug Designation in the European Union for both conditions. However, odronextamab has not yet received approval from any regulatory authority and remains in clinical development.
Regeneron, a leading biotechnology firm, is known for its track record of developing FDA-approved treatments for serious diseases, largely originating from its in-house laboratories. The company continues to enhance drug development through its proprietary VelociSuite® technologies and extensive genetics research.
This report is based on a press release statement from Regeneron Pharmaceuticals, Inc.
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