Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Pictured: Exterior of the FDA headquarters in Maryland/ iStock/Grandbrothers
Regeneron’s Biologics License Application for its bispecific antibody odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma was hit with a regulatory setback Monday, as the company announced that it has been issued Complete Response Letters from the FDA.
According to Regeneron, the “only approvability issue” cited by the FDA in its Complete Response Letters (CRLs) “is related to the enrollment status of the confirmatory trials.” The CRLs included one for relapsed/refractory follicular lymphoma (R/R FL) and another for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), each after two or more lines of systemic therapy. Regeneron also noted that the CRLs did not reveal any approval issues with odronextamab’s efficacy or safety, trial design, labeling or manufacturing.
The company has been enrolling patients in multiple Phase III trials for the drug as it looks to treat lymphoma patients in earlier lines of treatment. However, the FDA required that the trials include both dose-finding and confirmatory portions. Enrollment in dose-finding had already started but the CRLs show that the confirmatory aspects of these trials should have already begun and that the timelines to completion should have been agreed upon prior to resubmission.
“Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible. Regeneron plans on sharing updates on enrollment and regulatory timelines later this year,” the company said in a statement.
The drug was given priority review by the FDA last year and was also showing positive results. Of 128 patients assessed in a Phase II trial, 80% achieved an objective response while 73% had a complete response. Odronextamab in Phase II also showed the median duration of a response was 23 months, with the median time for a full response at 24 months. The average time for progression-free survival was 28 months.
In August 2023, the European Medicines Agency started a regulatory review of the drug, which is still ongoing. The European Union has also given odronextamab orphan drug designation.
Regeneron is not the only company to be slapped with CRLs recently. Earlier this month, the FDA rejected Viatris and Mapi Pharma’s formulation of glatiramer acetate—called GA Depot 40—for treating relapsing forms of multiple sclerosis. However, no details were provided as to why the letter was handed down.
On the positive side of the regulatory ledger, the FDA last month accepted Regeneron and Sanofi’s supplemental BLA to expand Dupixent into chronic obstructive pulmonary disease.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
