Regeneron Pharmaceuticals (REGN) said Wednesday that the US Food and Drug Administration has accepted for review the resubmission of its biologics license application for odronextamab drug, a treatment for relapsed/refractory follicular lymphoma after two or more lines of systemic therapy.
The target action date for the agency's decision is July 30, the company said.
The acceptance of the resubmission follows the achievement of target mandated by the agency in a confirmatory trial. The resubmission is supported by data from two trials, which showed that the drug had an overall response rate of 80% and a 74% complete response rate, the company said.
Follicular lymphoma is one of the most common subtypes of B-cell non-Hodgkin lymphoma.
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