Source facts
FDA issued an approval letter for ZYNLONTA on 2026-02-24. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZYNLONTA — FDA Approval Letter (BLA 761196)
Issued to ADC Therapeutics SA. Application is approved as submitted.
Issued
February 24, 2026Application
BLA • 761196
Product
ZYNLONTA
Company
ADC Therapeutics SA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZYNLONTA?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761196.
- 3Submission: supplement.
- 4Sponsor: ADC Therapeutics SA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZYNLONTA approval letter
Is ZYNLONTA FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761196 for ZYNLONTA, sponsored by ADC Therapeutics SA, on February 24, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761196?
BLA 761196 is the application under which FDA issued this approval letter for ZYNLONTA to ADC Therapeutics SA. The letter is dated February 24, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.