Regeneron Pharmaceuticals revealed that the FDA has rejected odronextamab, the biotech's investigational therapy for certain types of lymphoma.
The agency has issued complete response letters for the BLAs for odronextamab in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The only approvability issue noted in the CRLs was related to the enrollment status of the confirmatory trials.
Odronextamab, a CD20xCD3 bispecific antibody, is engineered to connect CD20, a protein found on the surface of cancer cells, with CD3, which is expressed on T-cells. This way, odronextamab harnesses the body's own immune system to fight cancer.
Regeneron has submitted the BLAs for odronextamab back in September 2023, supported by phase 1 and a subsequent crucial phase 2 study, ELM-1 and ELM-2.
Despite the setback, the FDA did not raise concerns over the drug's efficacy, safety, trial design, labeling or manufacturing processes. Regeneron has been actively enrolling patients in multiple phase 3 trials for odronextamab as part of the OLYMPIA program, which required both dose-finding and confirmatory portions. According to Regeneron, enrollment in the dose-finding portion of the trials has begun, but the CRLs indicate that the confirmatory portions of the trials should already be underway and that a timeline for completion needs to be set prior to resubmission. Regeneron is committed to working closely with the FDA.
Meanwhile, the European Medicines Agency continues its review of odronextamab for the same indications.
