FDA rejects Regeneron’s bispecific for lymphoma over confirmatory trial status

Regeneron has hit a snag in its attempt to bring a new bispecific antibody to the market, as the FDA rejected odronextamab across two types of blood cancers.

According to the company, the “only approvability issue is related to the enrollment status of the confirmatory trials,” and the agency didn’t identify any problems with efficacy, safety, trial design, labeling or manufacturing in the complete response letters.

The biotech had sought approval in relapsed/refractory follicular lymphoma as well as relapsed/refractory diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. At ASH in December, Regeneron presented Phase 2 data showing a 52% response rate in DLBCL.

Per FDA requirements, its Phase 3 trials include both dose-finding and confirmatory portions, Regeneron said. While it’s begun enrolling for the dose-finding portion, “the CRLs indicate that the confirmatory portions of these trials should…
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