Source facts
FDA issued an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LUNSUMIO / LUNSUMIO VELO — FDA Approval Letter (BLA 761263)
Issued to GENENTECH INC. Application is approved as submitted.
Issued
June 23, 2026Application
BLA • 761263
Product
LUNSUMIO / LUNSUMIO VELO
Company
GENENTECH INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LUNSUMIO / LUNSUMIO VELO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: BLA 761263.
- 3Submission: supplement.
- 4Sponsor: GENENTECH INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LUNSUMIO / LUNSUMIO VELO approval letter
Is LUNSUMIO / LUNSUMIO VELO FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761263 for LUNSUMIO / LUNSUMIO VELO, sponsored by GENENTECH INC, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761263?
BLA 761263 is the application under which FDA issued this approval letter for LUNSUMIO / LUNSUMIO VELO to GENENTECH INC. The letter is dated June 23, 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.