Issued to Checkpoint Therapeutics, Incorporated. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 15, 2023Application
BLA • 761297
Product
UNLOXCYT
Company
Checkpoint Therapeutics, Incorporated
Review center
Other
Stage
Final Decision
Response due
January 1, 2026
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Checkpoint Therapeutics, Incorporated on December 15, 2023.
BLA 761297 is the application under which FDA issued this complete response letter for UNLOXCYT to Checkpoint Therapeutics, Incorporated. It was reviewed by FDA Other. The letter is dated December 15, 2023.
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.