← FDA DRUG APPROVALS

FDA BLA · BLA761170

PHESGO

pertuzumab, trastuzumab, and hyaluronidase-zzxf

Sponsor: GENENTECH INC

APPLICATION
BLA761170
TYPE
BLA
ORIGINAL APPROVAL
2020-06-29
LATEST ACTION
2026-05-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PHESGOPrescription
PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF 1,200MG · INJECTABLE · SUBCUTANEOUS
PHESGOPrescription
PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF 600MG · INJECTABLE · SUBCUTANEOUS

Approval history

2026-05-18Labeling · Supplement 16 · standard — Label ↗AP
2024-11-22Efficacy · Supplement 7 · standard — Label ↗AP
2020-06-29Type 4 - New Combination · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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