Wednesday, June 10, 2026

Drug profile · INN

pertuzumab

pertuzumab (PERJETA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Hoffmann-La Roche. Route of administration: single-use. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01FD02
US status approved
Patents linked 2
Pipeline programs 22
News articles 0
Drug details — pertuzumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
SINGLE-USE
Patents
2
Programs
22
Data quality
0.84

Quick answer

pertuzumab (PERJETA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Hoffmann-La Roche. Route of administration: single-use. Current US regulatory status: approved.

Key facts

INN pertuzumab
Brand PERJETA
Mechanism Receptor protein-tyrosine kinase erbB-2 inhibitor
Target Receptor tyrosine-protein kinase erbB-2
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route SINGLE-USE
Formulation VIAL
ATC code L01FD02

Mechanism of action

Receptor protein-tyrosine kinase erbB-2 inhibitor

Primary target: Receptor tyrosine-protein kinase erbB-2

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. 2022-009 Phase 3 · Ningbo Cancer Hospital · metastatic breast cancer
  2. CTRIAL‐IE-22‐01 Phase 3 · Ningbo Cancer Hospital · Early stage HER2-positive breast cancer
  3. D967RC00001 Phase 3 · AstraZeneca · Early stage HER2-positive breast cancer (T stage >= T3, lymp
  4. D967UC00001 Phase 3 · AstraZeneca · HER2-positive metastatic breast cancer
  5. FM-17-B01 Phase 3 · Telethon Foundation · Invasive Breast Cancer
  6. HCB-ONC002 Phase 3 · George Institute for · HER2-positive early breast cancer
  7. IFOM-CPT0092022PO008 Phase 3 · Telethon Foundation · Colon cancer
  8. ML42502 Phase 3 · HOFFMANN-LA ROCHE · HER2-POSITIVE EARLY BREAST CANCER

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 11654199

    Thienoazepine immunoconjugates, and uses thereof

    Expires Mon May 18 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11400164

    Immunoconjugates targeting HER2

    Expires Mon Jul 28 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is pertuzumab?

pertuzumab (PERJETA) is a receptor protein-tyrosine kinase erbb-2 inhibitor. Associated with Hoffmann-La Roche. Route of administration: single-use. Current US regulatory status: approved.

What is the brand name for pertuzumab?

PERJETA is a marketed brand name for pertuzumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pertuzumab?

pertuzumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.