← FDA DRUG APPROVALS

FDA BLA · BLA761115

TRODELVY

sacituzumab govitecan

Sponsor: IMMUNOMEDICS INC

APPLICATION
BLA761115
TYPE
BLA
ORIGINAL APPROVAL
2020-04-22
LATEST ACTION
2026-06-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRODELVYPrescription
SACITUZUMAB GOVITECAN-HZIY 180MG · INJECTABLE · INJECTION

Approval history

2026-06-24Efficacy · Supplement 64 · standard — Letter ↗AP
2026-06-24Efficacy · Supplement 63 · standard — Letter ↗AP
2025-03-26Labeling · Supplement 59 · standard — Label ↗AP
2024-11-22Efficacy · Supplement 58 · priority — Label ↗AP
2023-02-03Efficacy · Supplement 35 · priority — Label ↗AP
2023-01-06Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2022-12-05Labeling · Supplement 31 · standard — Letter ↗AP
2022-06-03Labeling · Supplement 23 · standard — Letter ↗AP
2021-04-13Efficacy · Supplement 9 · priority — Label ↗AP
2021-04-07Efficacy · Supplement 13 · priority — Letter ↗AP
2021-04-07Efficacy · Supplement 5 · priority — Letter ↗AP
2020-04-22Type 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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