Issued to GlaxoSmithKline LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 23, 2025Application
BLA • 761440
Product
BLENREP
Company
GlaxoSmithKline LLC
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Safety and adverse events, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to GlaxoSmithKline LLC on October 23, 2025.
BLA 761440 is the application under which FDA issued this complete response letter for BLENREP to GlaxoSmithKline LLC. The letter is dated October 23, 2025.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.