Regeneron Updates Progress on Biologics License Application for Odronextamab
Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), each occurring after two or more lines of systemic therapy. The sole concern for approval is associated with the status of enrollment in the confirmatory trials. The CRLs, one for R/R FL and one for R/R DLBCL did not highlight any concerns regarding the clinical effectiveness or safety of odro...