Source facts
FDA issued an approval letter for KADCYLA on 2026-03-30. The source metadata identifies BLA 125427 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
KADCYLA — FDA Approval Letter (BLA 125427)
Issued to GENENTECH. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for KADCYLA?
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 125427.
- 3Submission: supplement.
- 4Sponsor: GENENTECH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the KADCYLA approval letter
Is KADCYLA FDA approved?
This letter documents an FDA approval action: FDA approved BLA 125427 for KADCYLA, sponsored by GENENTECH, on March 30, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 125427?
BLA 125427 is the application under which FDA issued this approval letter for KADCYLA to GENENTECH. The letter is dated March 30, 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.