Source facts
FDA issued an approval letter for ENHERTU on 2026-05-19. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ENHERTU — FDA Approval Letter (BLA 761139)
Issued to DAIICHI SANKYO. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ENHERTU?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761139.
- 3Submission: supplement.
- 4Sponsor: DAIICHI SANKYO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ENHERTU approval letter
Is ENHERTU FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761139 for ENHERTU, sponsored by DAIICHI SANKYO, on May 19, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761139?
BLA 761139 is the application under which FDA issued this approval letter for ENHERTU to DAIICHI SANKYO. The letter is dated May 19, 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.