FDA Issues Response Letters for Regeneron's Cancer Drug Odronextamab
===============
#5b5101d7 ver:0.1
The U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) to Regeneron Pharmaceuticals regarding its Biologics License Application (BLA) for the cancer drug odronextamab. The CRLs address the drug's use for relapsed/refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) and cite the need for further progress in confirmatory trial enrollment as the sole issue preventing approval. The FDA did not raise concerns about the drug's efficacy or safety, trial design, labeling, or manufacturing processes .
Regeneron has committed to working with the FDA to expedite the availability of odronextamab. The company will focus on addressing the issue of confirmatory trial enrollment and aims to make progress in this area to gain FDA approval. The drug...
#newstr #Fda #RegeneronPharmaceuticals #Odronextamab #CancerDrug #CompleteResponseLetters #BiologicsLicenseApplication #Relapsed/refractoryFollicularLymphoma #DiffuseLargeBcellLymphoma #ConfirmatoryTrialEnrollment #Efficacy #Safety #TrialDesign #Labeling #ManufacturingProcesses #EuropeanMedicinesAgency