FDA Approves Perjeta (pertuzumab) for HER2-Positive Breast Cancer

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FDA Published April 29, 2026 Medically reviewed April 29, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider Perjeta in combination with trastuzumab and chemotherapy for HER2-positive breast cancer across metastatic and early stages.

The FDA has approved Perjeta (pertuzumab), a HER2/neu receptor antagonist, for the treatment of adults with HER2-positive breast cancer. Perjeta is indicated for use in combination with trastuzumab and docetaxel for patients with metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Additionally, it is approved for neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early stage breast cancer (tumor >2 cm or node positive) and for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. The approval provides a new targeted therapy option for HER2-positive breast cancer, a subtype associated with aggressive disease. Clinicians should note that Perjeta is administered intravenously and requires HER2 testing using FDA-approved tests.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Perjeta is a HER2/neu receptor antagonist. It binds to the extracellular domain of HER2, inhibiting ligand-dependent heterodimerization and downstream signaling.

Indication & Patient Population

Perjeta is indicated for use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is also indicated for neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive) as part of a complete treatment regimen, and for adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

Dosing & Administration

For intravenous infusion only. Initial dose: 840 mg over 60 minutes, followed by 420 mg over 30-60 minutes every 3 weeks. Administer sequentially with trastuzumab (or trastuzumab hyaluronidase-oysk) and taxane. In MBC, docetaxel initial dose 75 mg/m2, may escalate to 100 mg/m2. In neoadjuvant, administer every 3 weeks for 3-6 cycles. In adjuvant, administer every 3 weeks for up to 18 cycles (1 year). Assess LVEF before and during treatment. Verify pregnancy status before initiation.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Boxed Warning: Assess LVEF prior to initiation and at regular intervals. Warnings include left ventricular dysfunction, embryo-fetal toxicity, and infusion-related reactions. Verify pregnancy status in females of reproductive potential.

Place in Therapy

Perjeta is a targeted therapy for HER2-positive breast cancer, used in combination with trastuzumab and chemotherapy. It is indicated for both metastatic and early breast cancer settings, including neoadjuvant and adjuvant treatment.

Study Details

Study typeFda approval

PublishedJun 2012

View Original Abstract ↓

1 INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ( 1.1 ) Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ( 1.2 , 2.2 , 14.2 ) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence ( 1.2 , 2.2 , 14.3 ) 1.1 Metastatic Breast Cancer (MBC) PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] . 1.2 Early Breast Cancer (EBC) PERJETA is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] . the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence [see Dosage and Administration (2.2) and Clinical Studies (14.3) ] .