On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular lymphoma (R/R FL). The FDA’s PDUFA target action date is 30 July 2025.
Regeneron’s odronextamab BLA for R/R FL or R/R diffuse large B-cell lymphoma (DLBCL) was first accepted by the FDA for priority review in September 2023, with a target action date of 31 March 2024. In March 2024, the FDA issued complete response letters (CRLs), one for each indication, relating to enrolment status in confirmatory trials evaluating the medicine. According to Regeneron, the CRLs did not identify any issues regarding efficacy, safety, trial design or manufacturing of odronextamab.
Regeneron’s BLA resubmission for R/R FL was based on achievement of the FDA-mandated enrolment target for the OLYMPIA-1 Phase 3 confirmatory trial of odronextamab in R/R FL.
Odronextamab was approved in Europe in August 2024, as Ordspono™, for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy.