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FDA BLA · BLA761121

POLIVY

polatuzumab vedotin

Sponsor: GENENTECH

APPLICATION
BLA761121
TYPE
BLA
ORIGINAL APPROVAL
2019-06-10
LATEST ACTION
2026-03-18
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

POLIVYPrescription
POLATUZUMAB VEDOTIN-PIIQ 140MG/VIAL · POWDER · INTRAVENOUS
POLIVYPrescription
POLATUZUMAB VEDOTIN-PIIQ 30MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-03-18Labeling · Supplement 17 · standard — Letter ↗AP
2023-04-19Efficacy · Supplement 8 · standard — Label ↗AP
2020-09-18Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2019-06-10Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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