PERJETA (pertuzumab)
PERJETA is indicated for the treatment of Metastatic Breast Cancer; Early Breast Cancer.
How PERJETA Works
Pertuzumab binds to the extracellular dimerization domain of the HER2 protein, preventing it from pairing with other HER family members such as EGFR, HER3, and HER4. This blockade inhibits ligand-initiated intracellular signaling through the MAP kinase and PI3K pathways, which can result in cell growth arrest and apoptosis. Additionally, the drug mediates antibody-dependent cell-mediated cytotoxicity to target tumor cells. When used with trastuzumab, the combination provides augmented anti-tumor activity in HER2-overexpressing models.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-06-08
- Patent Cliff
- 2024
- Revenue
- $769M (Q4-2025)
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
PERJETA Approval History
What PERJETA Treats
2 indicationsPERJETA is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic Breast Cancer
- Early Breast Cancer
PERJETA Boxed Warning
LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause...
WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1) (8.3) ]. WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function. ( 2.3 , 5.1 , 6.1 ) Embryo-fetal Toxicity: Exposure to PERJETA can cause embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception. ( 5.2 , 8.1 , 8.3 )
PERJETA Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
PERJETA Biosimilars
1 FDA-approved1 can be substituted at the pharmacy without calling the prescriber.
What are biosimilars? Lower-cost alternatives to PERJETA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
PERJETA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PERJETA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PERJETA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PERJETA
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
173 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT06445400 | BL-M07D1-205 | Ph 2 | active not recruiting | A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer |
| NCT02320435 | MO29406 2014-002048-42, 2023-505102-42-00 | Ph 3 | active not recruiting | A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial |
| NCT07578116 | S2511 NCI-2026-02627, S2511 | Ph 3 | not yet recruiting | Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis |
| NCT05319873 | 21-001819 NCI-2021-11707 | Ph 1, Ph 2 | active not recruiting | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer |
| NCT06876714 | A012303 NCI-2024-10478 | Ph 3 | recruiting | ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab |
| NCT04266249 | EA1181 NCI-2019-07439, EA1181 | Ph 2 | active not recruiting | CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy |
| NCT07565324 UC HER | 202509103MINB | Ph 2 | not yet recruiting | Phase II Study of Ultrasound and ctDNA Guided Neoadjuvant Systemic Therapy for Patients With HER2-positive Early Breast Cancer (UC HER Trial) |
| NCT07102381 EmpowHER 208 | JZP598-208 2025-523204-68-00 | Ph 2 | recruiting | A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer |
| NCT03417544 results posted | 17-546 | Ph 2 | active not recruiting | Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC |
| NCT07402473 EUREKA | 042507 Pro2025002581 | Ph 2 | recruiting | Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer |
| NCT07545044 | JSKN003-008 | Ph 2 | not yet recruiting | A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer |
| NCT05132582 HER2CLIMB-05 | SGNTUC-028 C4251007, 2023-503826-37-00 | Ph 3 | active not recruiting | A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer |
| NCT03820141 DTP results posted | Pro00020917 | Ph 2 | active not recruiting | Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer |
| NCT02326974 results posted | 14-409 | Ph 2 | active not recruiting | T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA |
| NCT07527806 | L259061 | Ph 2 | not yet recruiting | Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging |
| NCT07528898 | OBU-BC-II-279 | Ph 2 | not yet recruiting | Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. |
| NCT06136897 results posted | NCI-2023-09506 NCI-2023-09506, EAY131-J | Ph 2 | active not recruiting | Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) |
| NCT02390427 | 15-024 | Ph 1 | completed | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer |
| NCT07441460 | KN026-007 | Ph 3 | recruiting | A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer |
| NCT07518173 | BL-M07D1-307 | Ph 3 | not yet recruiting | A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer |
| NCT04208178 EPIK-B2 | CBYL719G12301 2024-512050-13-00 | Ph 3 | active not recruiting | Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation |
| NCT07371585 TOP-REAL | SOLTI-2402 2025-521805-41-00 | Ph 2 | recruiting | Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management |
| NCT07335081 | RJBC2401 | Ph 2 | recruiting | ctDNA in HER2+ EBC Neoadjuvant Treatment |
| NCT05323955 BRIDGET | Pro00109777 | Ph 2 | active not recruiting | Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib |
| NCT04253561 IPATHER | SOLTI-1507 2019-001526-94 | Ph 1 | completed | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients |
| NCT03006172 | GO39374 2016-003022-17, 2023-508124-36-00 | Ph 1 | active not recruiting | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer |
| NCT05325632 | MCC-20915 | Ph 2 | recruiting | Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab |
| NCT07421141 Opti-HER2 | Opti-HER2-2023 LEC #962/107 | Ph 2 | active not recruiting | De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer |
| NCT07377643 | CIBI354B302 | Ph 3 | recruiting | IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer |
| NCT05113251 | D967RC00001 2023-505210-18-00, 2021-000603-21 | Ph 3 | active not recruiting | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer |
| NCT04784715 | D967UC00001 2023-507904-30-00, 2020-004074-21 | Ph 3 | active not recruiting | Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) |
| NCT06686394 | 1022-009 MK-1022-009, jRCT2041250022 | Ph 1, Ph 2 | recruiting | Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) |
| NCT02947685 PATINA results posted | AFT-38 | Ph 3 | active not recruiting | Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer |
| NCT07407920 | 2024-1206 NCI-2025-08252, 2024-1206 | Ph 2 | active not recruiting | Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial |
| NCT03101748 results posted | 2016-0537 NCI-2017-00813, 2016-0537 | Ph 1, Ph 2 | terminated | Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer |
| NCT03365882 results posted | S1613 NCI-2016-01422, S1613 | Ph 2 | completed | S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery |
| NCT04588545 | MCC-20487 ML41590 | Ph 1, Ph 2 | recruiting | Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease |
| NCT07393425 | RJBC2502 | Ph 2 | recruiting | Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer |
| NCT01796197 results posted | 12-497 | Ph 2 | completed | Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa |
| NCT06771622 | HCB101-201 | Ph 1, Ph 2 | active not recruiting | Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors |
| NCT02057133 | 15252 I3Y-MC-JPBH | Ph 1 | active not recruiting | A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread |
| NCT07340398 TAYLOR | 2025-1587 | Ph 2 | recruiting | Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer |
| NCT03199885 results posted | NCI-2017-01119 NCI-2017-01119, NRG-BR004 | Ph 3 | completed | Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer |
| NCT00781612 | TDM4529g BO25430, 2010-021067-32 | Ph 2 | active not recruiting | A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies |
| NCT04538742 DB-07 | D967JC00001 2023-505309-18-00, 2019-004531-22 | Ph 1, Ph 2 | active not recruiting | A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer |
| NCT05786716 DETERMINE | CRUKD/21/004 - Treatment Arm 4 IRAS ID: 1004057 | Ph 2, Ph 3 | recruiting | DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With HER2 Amplification or Activating Mutations |
| NCT05180006 BIS-Program | 2020-004696-41 2020/3130 | Ph 2 | terminated | Impact of Neoadjuvant Immunotherapy in Early Stage Breast Cancer Before Standard Therapy |
| NCT01358877 APHINITY results posted | BO25126 TOC4939G, 2010-022902-41 | Ph 3 | completed | A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer |
| NCT04193059 PANSY | 2018-68-1461 | Ph 3 | active not recruiting | Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer |
Showing 50 of 173 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PERJETA FDA Label Details
Indications & Usage
FDA Label (PDF)PERJETA is indicated for the treatment of Metastatic Breast Cancer; Early Breast Cancer.
WARNING: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clini...
Pro Intelligence Preview
Deep insights for PERJETA
Revenue Insights
- • Q4-2025: $769M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2024
- • Generic/biosimilar risk
Trial Analysis
- • 177 total trials
- • Stage: Growth
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment