FDA issued CRLs for the BLAs for odronextamab in R/R follicular lymphoma (FL) and in R/R DLBCL, each after two or more lines of systemic therapy
“The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing.”
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