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FDA BLA · BLA761309

COLUMVI

glofitamab

Sponsor: GENENTECH INC

APPLICATION
BLA761309
TYPE
BLA
ORIGINAL APPROVAL
2023-06-15
LATEST ACTION
2026-06-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

COLUMVIPrescription
GLOFITAMAB-GXBM 10MG/10ML(1MG/ML) · INJECTABLE · INJECTION
COLUMVIPrescription
GLOFITAMAB-GXBM 2.5MG/2.5ML(1MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-22Labeling · Supplement 7 · standard — Label ↗AP
2026-05-28Labeling · Supplement 6 · standard — Letter ↗AP
2025-10-27Labeling · Supplement 4 · standard — Label ↗AP
2025-06-09Labeling · Supplement 3 · standard — Label ↗AP
2023-06-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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