Drugs / Pertuzumab
Pertuzumab
also known as
Perjeta · rhuMAb 2C4 · Combination product: Trastuzumab + Pertuzumab · Omnitarg · Pmab · QL1209 · QL1209 (A pertuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd) · ZRC-3277
Monoclonal antibody targets ERBB2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 17 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 2 milestones | |||||
| Filed | US (FDA) | — | female breast nipple and areola cancer | 2020-02-24 | “FDA has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin ® (trastuzumab)” gene.com ↗ |
| Filed | Japan (PMDA) | Perjeta | female breast nipple and areola cancer | 2017-10-25 | “filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, "Perjeta” chugai-pharm.co.jp ↗ |
| Filed Her2-receptor negative breast cancer 5 milestones | |||||
| Filed | US (FDA) | Enhertu | Her2-receptor negative breast cancer | 2025-09-24 | “Application (sBLA) for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | — | Her2-receptor negative breast cancer | 2022-09-29 | “Chugai files a new drug application for fixed-dose subcutaneous combination of pertuzumab and trastuzumab (same monoclonal antibodies as in Perjeta and Herceptin) in Japan” chugai-pharm.co.jp ↗ |
| Filed | US (FDA) | — | Her2-receptor negative breast cancer | 2020-02-25 | “today announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta®...” roche.com ↗ “The FDA accepted Roche’s Biologics License Application for the fixed-dose combination of Perjeta and Herceptin with hyaluronidase” roche.com ↗ |
| Filed | US (FDA) | Perjeta | Her2-receptor negative breast cancer | 2017-09-28 | “FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta®” gene.com ↗ |
| Filed | EU (EMA) | Perjeta | Her2-receptor negative breast cancer | — | “Roche recently submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for the Perjeta regimen as a neoadjuvant treatment for people with...” gene.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (6) | US (FDA) | PERJETA | — | 2013-04-12 – 2026-04-23 | fda.gov ↗ |
| Filed | China (NMPA) | — | — | 2025-11-12 | “MARKETING AUTHORISATION APPLICATION FOR PERTUZUMAB INJECTION ACCEPTED BY THE NMPA” irasia.com ↗ |
| Label expansion | US (FDA) | PHESGO | — | 2024-11-22 | fda.gov ↗ |
| Approved | EU (EMA) | Perjeta | — | 2013-03-04 | europa.eu ↗ |
| Approved | US (FDA) | PERJETA | — | 2012-06-08 | fda.gov ↗ |
Trials 212 · started per year
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US approved 2012
EU approved 2013
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 118 trials · 3 met primary | ||||||
| Phase 1 | NCT06162559 | Dec 2023 → Aug 2026 overdue | breast cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT05275010 | May 2022 → May 2023 | — | Hoffmann-La Roche | Completed | Met primary |
| Phase 1 | NCT05385705 | May 2022 → Jul 2024 | breast neoplasm | Vall d'Hebron Institute of Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04188548 | Dec 2019 → Jun 2020 overdue | breast cancer, endometrial cancer | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03716180 | Nov 2018 → Oct 2020 overdue | breast cancer | Dana-Farber Cancer Institute | Active not recruiting | Met primary |
| Phase 1 | NCT02598427 | May 2017 → Feb 2018 | HER2 positive breast carcinoma | Kimberly Blackwell | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03006172 | Dec 2016 → Dec 2026 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02738970 | Jun 2016 → May 2018 | female breast carcinoma | Hoffmann-La Roche | Completed | Met primary |
| Phase 1 | NCT02605915 | Dec 2015 → Nov 2019 | HER2 positive breast carcinoma, female breast carcinoma, triple-negative breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02390427 | Apr 2015 → Dec 2022 | breast carcinoma | Nancy Lin, MD | Completed | No outcome recorded |
| Phase 1 | NCT02060253 | Apr 2014 → Jun 2018 | HER2 positive breast carcinoma, male breast carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02057133 | Mar 2014 → Mar 2021 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01918254 | Aug 2013 → Oct 2016 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02507375 | Sep 2006 → Dec 2008 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02490475 | Feb 2004 → Apr 2006 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02494596 | Jan 2004 → Sep 2005 | neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00027027 | Nov 2001 → Aug 2003 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/218 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07612215 | May 2026 → May 2029 expected | triple-positive breast carcinoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07140393 | Oct 2025 → Oct 2027 expected | neoplasm | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06686394 | Feb 2025 → Apr 2030 expected | breast cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05574881 | Sep 2022 → Jan 2025 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04538742 | Dec 2020 → Jan 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04588545 | Dec 2020 → Apr 2027 expected | HER2 positive breast carcinoma, malignant tumor of meninges | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04215003 | Jan 2020 → Dec 2024 | breast cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT03881878 | May 2019 → Oct 2022 | HER2 positive breast carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT03101748 | Feb 2018 → May 2025 | inflammatory breast carcinoma, metastatic carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03304080 | Dec 2017 → Jul 2026 overdue | breast neoplasm | Icahn School of Medicine at Mount Sinai | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02139358 | Sep 2014 → Apr 2018 | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02345772 | Jul 2014 → Nov 2015 | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer | Western Regional Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02336984 | Jun 2014 → Apr 2016 | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02120911 | Jan 2014 → Feb 2017 | esophageal cancer | Academic Medical Center - University of Amsterdam | Completed | Met primary |
| Phase 1/2 | NCT00951665 | Aug 2009 → Feb 2012 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00934856 | Jul 2009 → Oct 2013 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT00875979 | May 2009 → Aug 2011 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT00551421 | Oct 2007 → Nov 2010 | colon adenocarcinoma, rectum adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2123 trials · 8 met primary · 7 missed | ||||||
| Phase 2 | NCT07848633 | Oct 2026 → Dec 2029 expected | HER2 positive breast carcinoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07802418 | Oct 2026 → Jun 2031 expected | malignant pancreatic neoplasm | Herlev Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07795424 | Sep 2026 → Mar 2028 expected | HER2 positive breast carcinoma | Shengjing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07857226 | Sep 2026 → Jun 2028 expected | breast cancer | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07610720 | Jun 2026 → Nov 2028 expected | HER2 positive breast carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07565324 | Apr 2026 → Dec 2029 expected | HER2 positive breast carcinoma | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07402473 | Mar 2026 → Dec 2027 expected | HER2 positive breast carcinoma | Rutgers, The State University of New Jersey | Recruiting | No outcome recorded |
| Phase 2 | NCT07647263 | Mar 2026 → Jun 2029 expected | HER2 positive breast carcinoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT07459673 | Mar 2026 → Mar 2030 expected | HER2 positive breast carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07393425 | Feb 2026 → Sep 2027 expected | HER2 positive breast carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Show all 123 trials opens the full record — a long page | ||||||
| Phase 2/36 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07294508 | Feb 2026 → Jan 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07294534 | Jan 2026 → Sep 2028 expected | HER2 positive breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06891833 | Jun 2025 → Dec 2028 expected | HER2 positive breast carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05786716 | Mar 2023 → Oct 2029 expected | cancer, colorectal neoplasm, gallbladder neoplasm, hematopoietic and lymphoid cell neoplasm +7 | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05722886 | Mar 2023 → Oct 2029 expected | cancer, hematopoietic and lymphoid cell neoplasm | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02581462 | Jun 2016 → Jul 2020 | gastric cancer, gastroesophageal junction adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | Met primary |
| Phase 333 trials · 8 met primary · 5 missed | ||||||
| Phase 3 | NCT07683754 | Sep 2026 → Jul 2030 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07377643 | Feb 2026 → Apr 2028 expected | HER2 positive breast carcinoma | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06876714 | Sep 2025 → Mar 2028 expected | HER2 positive breast carcinoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06490536 | Oct 2024 → Mar 2026 overdue | colorectal cancer | IFOM ETS - The AIRC Institute of Molecular Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT05883852 | Jun 2023 → Jul 2031 expected | HER2 positive breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT05256225 | Nov 2022 → Oct 2027 expected | carcinosarcoma of the corpus uteri, endometrial clear cell adenocarcinoma, endometrial endometrioid adenocarcinoma, endometrial mixed adenocarcinoma +2 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05415215 | Jul 2022 → Nov 2024 | female breast carcinoma, inflammatory breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT05188313 | Mar 2022 → Jul 2027 expected | esophageal adenocarcinoma | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 3 | NCT05113251 | Oct 2021 → Mar 2025 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04784715 | Apr 2021 → Jul 2026 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05429684 | Jan 2021 → Feb 2024 | HER2 positive breast carcinoma | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 3 | NCT04547907 | Sep 2020 → Dec 2024 overdue | HER2 positive breast carcinoma | Henan Cancer Hospital | Recruiting | Met primary |
| Phase 3 | NCT04514419 | Jun 2020 → Sep 2024 overdue | breast cancer | BioRay Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03803553 | Apr 2020 → Dec 2026 expected | metastasis from malignant tumor of colon | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04193059 | Dec 2019 → Jul 2026 overdue | breast cancer | Fudan University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03811418 | Jan → Apr 2019 | HER2 positive breast carcinoma, female breast carcinoma | iOMEDICO AG | Withdrawn | No outcome recorded |
| Phase 3 | NCT04957212 | Aug 2018 → May 2020 | HER2 positive breast carcinoma | Cinnagen | Completed | No outcome recorded |
| Phase 3 | NCT03264547 | Aug 2017 → Dec 2024 | breast cancer | Japan Breast Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT02896855 | Sep 2016 → Jun 2018 | breast cancer | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02586025 | Mar 2016 → Oct 2017 | breast cancer | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02625441 | Dec 2015 → Jun 2025 overdue | breast cancer | Helsinki University Central Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02514681 | Aug 2015 → Dec 2018 | HER2 positive breast carcinoma | Japan Breast Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT02320435 | Feb 2015 → Dec 2026 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02125344 | Dec 2014 → Nov 2016 | HER2 positive breast carcinoma, breast mucinous carcinoma, female breast carcinoma, inflammatory breast carcinoma +1 | GBG Forschungs GmbH | Completed | Missed primary |
| Phase 3 | NCT02131064 | Jun 2014 → Dec 2015 | breast neoplasm | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT02019277 | Dec 2013 → Nov 2016 | female breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01774786 | Jun 2013 → Dec 2016 | gastric cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01684878 | Oct 2012 → Jan 2015 | ovarian cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01572038 | Jun 2012 → Sep 2019 | breast neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01358877 | Nov 2011 → Dec 2016 | breast cancer | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT01120184 | Jul 2010 → Sep 2014 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01026142 | Jan 2010 → May 2015 | breast cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT00567190 | Feb 2008 → May 2011 | breast cancer | Genentech, Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07695259 | May 2026 → Dec 2027 expected | HER2 positive breast carcinoma | Wen-Ming Cao | Recruiting | No outcome recorded |
| Phase 4 | NCT06641544 | Oct 2024 → Dec 2027 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT06578299 | Aug 2024 → Mar 2026 overdue | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02445586 | Aug 2015 → Sep 2018 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT07589972 | Apr 2026 → Dec 2027 expected | breast carcinoma by gene expression profile | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07377916 | Feb 2026 → Jun 2029 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| — | NCT07187752 | Sep 2025 → Dec 2026 expected | breast cancer | Shandong Cancer Hospital and Institute | Not yet recruiting | No outcome recorded |
| — | NCT07095023 | Aug 2025 → Dec 2026 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT05656079 | Jul 2021 → Sep 2024 | breast cancer | Shanghai Pudong Hospital | Unknown | No outcome recorded |
| — | NCT07115095 | Jan 2021 → Jan 2023 | HER2 positive breast carcinoma | Nanlin Li | Completed | No outcome recorded |
| — | NCT06907082 | Dec 2020 → Mar 2024 | breast cancer | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| — | NCT01048099 | Jan 2011 → Jul 2014 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04395508 | — | HER2 positive breast carcinoma | Genentech, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy123 trials | ||||||
| Phase 0 | NCT03387553 Background | Jun 2018 → Aug 2023 | HER2 positive breast carcinoma, female breast carcinoma, invasive breast carcinoma, male breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 0 | NCT01875666 Comparator | Aug 2013 → Dec 2016 | breast neoplasm | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT05825781 Comparator | Jul 2023 → Jan 2024 overdue | — | Mabscale, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05738993 Comparator | Aug 2022 → Apr 2023 | breast cancer | Biocad | Unknown | No outcome recorded |
| Phase 1 | NCT05471648 Comparator | May 2022 → Jan 2023 | breast cancer | EirGenix, Inc. | Completed | No outcome recorded |
| Show all 123 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 71
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Pfizer | Regulatory Pfizer’s TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer pfizer.com ↗
Today's FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. |
| 2026-09-01 | Alexion Pharmaceuticals, Inc. | Regulatory Enhertu plus pertuzumab approved in the EU as first new regimen in more than a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2026-07-24 | AstraZeneca | Regulatory Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2026-06-30 | HanchorBio Inc. | Results HanchorBio Showcases HCB101 Myeloid-Enhancer Strategy in Gastric Cancer and HNSCC at JCA-AACR 2026 hanchorbio.com ↗
In this setting, HCB101-based combination therapy demonstrated preliminary activity, including a 75% objective response rate and 100% disease control rate across the overall cohort. |
| 2026-06-24 | Pfizer | Regulatory FDA Approves Pfizer’s IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance pfizer.com ↗
With today’s FDA approval, IBRANCE becomes the first and only CDK4/6 inhibitor indicated for patients with HR+ metastatic breast cancer regardless of HER2 status, extending its impact to patients who continue to face challenges with treatment resistance. |
| 2026-05-29 | Shanghai Henlius Biotech | Regulatory Henlius' Pertuzumab Approved in China, Solidifying Breast Cancer Strategy as the First China-US-EU Approved Chinese Trastuzumab-Pertuzumab Combination henlius.com ↗
On May 29, 2026, Henlius (2696.HK) announced that the New Drug Application (NDA) for its independently developed pertuzumab biosimilar HANBEIYOU (trade name in US and Europe: POHERDY®) has been approved by the National Medical Products Administration (NMPA). |
| 2026-04-29 | Organon and Co | Regulatory European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product. |
| 2026-04-29 | Shanghai Henlius Biotech | Regulatory European Commission (EC) Approves Henlius and Organon’s POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe henlius.com ↗ |
| 2026-04-21 | Pfizer | Results Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026 pfizer.com ↗
These results support TUKYSA’s potential use as part of a chemotherapy-free, first-line maintenance strategy for HER2+ MBC. |
| 2026-04-01 | Shanghai Henlius Biotech | Regulatory Enhancing Treatment for Breast Cancer: China’s First Subcutaneous Pertuzumab/Trastuzumab Combination HLX319 Approved for Clinical Trial henlius.com ↗ |
| 2025-12-15 | AstraZeneca | Regulatory Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. |
| 2025-12-10 | Pfizer | Results TUKYSA Added to First-Line Maintenance Therapy Extends Median Progression-Free Survival by Over 8 Months in Patients with HER2+ Metastatic Breast Cancer pfizer.com ↗
In HER2CLIMB-05, the median progression-free survival (PFS) was 24.9 months (95% CI: 21.3-not reached) in the TUKYSA arm and 16.3 months (95% CI:12.6-18.7) in the placebo arm, representing an extension in median PFS of 8.6 months. |
| 2025-12-10 | Shanghai Henlius Biotech | Results Henlius Highlights Dual Progress in Breast Cancer Pipeline as HLX11 and HLX78 Data Release at ESMO Asia 2025 henlius.com ↗
At the ESMO Asia Congress 2025, Henlius announced data readouts from two breast cancer–related studies: results from the phase 3 equivalence study (NCT05346224) of HLX11 (trade name: POHERDY® in U.S.), the first and only FDA-approved biosimilar to PERJETA®, and the phase 1 pharmacokinetic (PK) and safety findings of the innovative endocrine therapy HLX78 (lasofoxifene) in healthy Chinese female adults. |
| 2025-11-17 | Organon and Co | Regulatory Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US organon.com ↗
POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers. |
| 2025-11-17 | Shanghai Henlius Biotech | Regulatory Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US henlius.com ↗
POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers. |
| 2025-11-12 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - MARKETING AUTHORISATION APPLICATION FOR PERTUZUMAB INJECTION ACCEPTED BY THE NMPA irasia.com ↗
MARKETING AUTHORISATION APPLICATION FOR PERTUZUMAB INJECTION ACCEPTED BY THE NMPA |
| 2025-10-18 | AstraZeneca | Results Enhertu followed by THP before surgery resulted in a pathologic complete response in 67% of patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗
Positive results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate. |
| 2025-09-24 | AstraZeneca | Regulatory Enhertu plus pertuzumab granted Priority Review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been accepted and granted Priority Review in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. |
| 2025-07-02 | Shanghai Henlius Biotech | Regulatory Henlius Receives New EMA GMP Certification, Accelerating European Market Entry of Two Biosimilar Candidates henlius.com ↗
According to the GMP mutual recognition system among European Union (EU) member states, it marks that the related production lines have met the EU GMP standards. |
| 2025-06-02 | AstraZeneca | Results Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial astrazeneca.com ↗
In a prespecified interim analysis, Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP (based on a hazard ratio [HR] of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.00001). |
| 2025-05-13 | Hoffmann-La Roche | Results Ten-year APHINITY data show Roche’s Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer roche.com ↗
After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. |
| 2025-05-13 | Chugai Pharmaceutical | Results Roche Announces New Ten-Year Data of Perjeta-Based Regimen for HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗
Ten-year APHINITY data show Roche’s Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer |
| 2025-05-12 | Genentech, Inc. | Results Ten-Year APHINITY Data Show Genentech’s Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. |
| 2025-05-07 | AstraZeneca | Results Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗ |
| 2025-04-21 | AstraZeneca | Results Enhertu plus pertuzumab demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival vs. THP as 1st-line therapy for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
The PFS improvement was seen across all pre-specified patient subgroups with Enhertu in combination with pertuzumab. |
| 2024-12-12 | Pfizer | Results Pfizer’s IBRANCE® in Combination with Standard-of-Care Therapies Extends Median Progression-Free Survival by Over 15 Months in Phase 3 PATINA Study in Patients with HR+, HER2+ Metastatic Breast Cancer pfizer.com ↗
This represents an extension in median PFS of over 15 months. |
| 2024-12-04 | Shanghai Henlius Biotech | Regulatory China NMPA Accepts Henlius' NDA for HLX11, an Pertuzumab Biosimilar Candidate henlius.com ↗
the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11 |
| 2024-09-30 | Organon and Co | Results Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11 organon.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 met the primary endpoint. |
| 2024-07-11 | Shanghai Henlius Biotech | Results Publication in Journal of Translational Medicine Highlighting Henlius' Dual HER2 Blockade Therapy Mechanism of Action henlius.com ↗
In contrast, pertuzumab disrupted the formation of HER2 heterodimer. |
| 2024-06-02 | AstraZeneca | Results Enhertu demonstrated a median progression-free survival of 13.2 months in HR-positive, HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy astrazeneca.com ↗
Results showed a confirmed ORR of 76.0% with Enhertu and 84.0% with Enhertu in combination with pertuzumab. |
| 2023-10-18 | Bolt Biotherapeutics, Inc. | Results Bolt Biotherapeutics to Present Data at the Society for Immunotherapy of Cancer’s 2023 Annual Meeting boltbio.com ↗
Company to debut preclinical data illustrating how the combination of trastuzumab ISAC and pertuzumab augments anti-tumor efficacy in multiple HER2+ tumor models relative to trastuzumab plus pertuzumab |
| 2023-09-25 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Phesgo, the Fixed-Dose Subcutaneous Combination of Perjeta and Herceptin for HER2-Positive Breast and Colorectal Cancer chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained regulatory approval today from the Ministry of Health, Labour and Welfare (MHLW) for Phesgo ® combination for Subcutaneous Injection |
| 2022-10-28 | Shanghai Henlius Biotech | Regulatory Henlius Pertuzumab Biosimilar HLX11 Received Clinical Trial Approval in EU for the Phase 3 MRCT henlius.com ↗
has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). |
| 2022-09-29 | Chugai Pharmaceutical | Regulatory Chugai Files New Drug Application in Japan for Fixed-Dose Subcutaneous Combination of Pertuzumab and Trastuzumab for HER2-Positive Breast and Colorectal Cancer chugai-pharm.co.jp ↗
Chugai files a new drug application for fixed-dose subcutaneous combination of pertuzumab and trastuzumab (same monoclonal antibodies as in Perjeta and Herceptin) in Japan |
| 2022-07-14 | Hoffmann-La Roche | Results Eight-year data from APHINITY study show Roche’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer roche.com ↗
For patients with lymph node (LN)-positive disease, results showed a 28% reduction in the risk of recurrence or death, corresponding to an absolute benefit at eight years of 4.9% (invasive disease-free survival [iDFS], hazard ratio [HR]=0.72, 95% confidence interval [CI] 0.60-0.87). |
| 2022-03-28 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Perjeta and Herceptin for Additional Indication of HER2-Positive Colorectal Cancer chugai-pharm.co.jp ↗
Combination therapy of Perjeta and Herceptin obtained regulatory approval for advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy |
| 2021-11-08 | Shanghai Henlius Biotech | Results Henlius Announces Successful Completion of Phase 1 Clinical Trial of Pertuzumab Biosimilar HLX11 henlius.com ↗
The results of this study demonstrated that HLX11 had similar pharmacokinetic and safety profiles to the reference drugs from different sources. |
| 2020-12-23 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer. |
| 2020-12-23 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives European Commission Approval For Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer. |
| 2020-11-13 | Halozyme Therapeutics | Regulatory Halozyme Announces CHMP Recommends EU Approval Of Roche's Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For HER2-Positive Breast Cancer halozyme.com ↗
Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future. |
| 2020-09-17 | Hoffmann-La Roche | Results Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020 roche.com ↗
Data from the phase II PHranceSCa study show the majority of patients prefer treatment with Phesgo™, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), compared to standard intravenous formulations. |
| 2020-06-29 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer roche.com ↗ |
| 2020-06-29 | Halozyme Therapeutics | Regulatory Halozyme Announces Roche Receives FDA Approval For Phesgo™ (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For The Treatment Of Patients With HER2-Positive Breast Cancer halozyme.com ↗
This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology. |
| 2020-02-25 | Hoffmann-La Roche | Regulatory FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer roche.com ↗ |
| 2020-02-25 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's ENHANZE® drug delivery technology in combination with intravenous (IV) chemotherapy for the treatment of eligible patients with HER2-positive breast cancer. |
| 2020-02-24 | Genentech, Inc. | Regulatory FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer gene.com ↗
FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer |
| 2019-12-12 | Hoffmann-La Roche | Results Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer roche.com ↗
Phase III FeDeriCa study showed non-inferior pharmacokinetics and comparable efficacy and safety with the fixed-dose combination when compared to intravenous formulations |
| 2019-12-12 | Halozyme Therapeutics | Results Data From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's ENHANZE® Drug Delivery Technology To Be Presented At San Antonio Breast Cancer Symposium halozyme.com ↗
The FeDeriCa study met its primary endpoint, with subcutaneous administration of the FDC showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta®. |
| 2019-12-11 | Hoffmann-La Roche | Results APHINITY six-year results strengthen evidence of clinical benefit with Roche’s Perjeta-based regimen roche.com ↗
These new data with longer follow-up show the continued effect of the Perjeta-based regimen and an increased invasive disease-free survival benefit. |
| 2019-12-11 | Genentech, Inc. | Results Genentech’s Fixed-dose Subcutaneous Combination of Perjeta and Herceptin Comparable to Intravenous Formulations in People With HER2-Positive Breast Cancer gene.com ↗
Phase III FeDeriCa study showed non-inferior pharmacokinetics and comparable efficacy and safety with new fixed-dose combination when compared to intravenous formulations |
| 2019-11-18 | Hoffmann-La Roche | Results Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium roche.com ↗
Results from phase III FeDeriCa study confirming the non-inferiority of a fixed-dose combination of Perjeta and Herceptin administered under the skin |
| 2019-09-13 | Hoffmann-La Roche | Results Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin showed non-inferiority when compared to intravenous formulations for people with HER2-positive breast cancer roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the phase III FeDeriCa study met its primary endpoint. |
| 2019-09-13 | Halozyme Therapeutics | Results Positive Results Announced From Phase 3 Trial Evaluating Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Halozyme's Enhanze® Drug Delivery Technology halozyme.com ↗
The study results demonstrated non-inferior levels of Perjeta® in the blood (pharmacokinetics) compared to standard intravenous (IV) infusion of Perjeta® plus Herceptin® and chemotherapy in patients with HER2-positive early breast cancer. |
| 2019-09-12 | Genentech, Inc. | Results Genentech’s Fixed Dose Subcutaneous Combination of Perjeta And Herceptin Showed Non-Inferiority When Compared to Intravenous Formulations for People With HER2-Positive Breast Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III FeDeriCa study met its primary endpoint. |
| 2019-06-03 | Hoffmann-La Roche | Results Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting roche.com ↗
End-of-study results in phase III CLEOPATRA study showed over a third (37%) of metastatic HER2-positive breast cancer patients in the Perjeta arm were alive at eight years |
| 2019-04-03 | MacroGenics | Results MacroGenics Reports Presentation of Data at the AACR Annual Meeting 2019 macrogenics.com ↗
In addition, the combination of margetuximab and pertuzumab mediated ADCC in vitro with greater potency than the combination of trastuzumab and pertuzumab. |
| 2018-10-10 | Chugai Pharmaceutical | Regulatory Anti-Cancer Agent “PERJETA ® ,” Approved for Additional Indication of “Neoadjuvant and Adjuvant Therapy for HER2-Positive Early Breast Cancer” chugai-pharm.co.jp ↗
With this supplemental approval, the indication of PERJETA has been broadened to “HER2-positive breast cancer.” |
| 2018-06-01 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. |
| 2018-04-27 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence roche.com ↗ |
| 2017-12-21 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer roche.com ↗
Today’s approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning. |
| 2017-12-20 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer gene.com ↗
today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. |
| 2017-10-25 | Chugai Pharmaceutical | Regulatory Anti-Cancer Agent "Perjeta ® " Filed for Additional Indication of Adjuvant Therapy for HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, "Perjeta ® I.V. Infusion 420mg/14mL [generic name: pertuzumab (genetical recombination)] (hereafter, Perjeta)” for the additional indication of adjuvant therapy for HER2-positive early breast cancer. |
| 2017-09-29 | Hoffmann-La Roche | Regulatory FDA grants Priority Review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer roche.com ↗
“We are pleased to receive Priority Review for the Perjeta-based regimen for the adjuvant treatment of HER2-positive early breast cancer,” said Sandra Horning, M.D., Roche's Chief Medical Officer and Head of Global Product Development. |
| 2017-09-28 | Genentech, Inc. | Regulatory FDA Grants Priority Review for Genentech’s Perjeta® (Pertuzumab) for Adjuvant Treatment of HER2-Positive Early Breast Cancer gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC). |
| 2017-06-05 | Hoffmann-La Roche | Results APHINITY study shows Roche’s Perjeta-based regimen reduced the risk of invasive cancer returning compared to Herceptin and chemotherapy in HER2-positive early breast cancer roche.com ↗
At three years, 94.1% of people treated with the Perjeta-based regimen did not have their breast cancer return compared to 93.2% treated with Herceptin and chemotherapy. |
| 2017-06-05 | Genentech, Inc. | Results APHINITY Study Shows Genentech’s Perjeta-Based Regimen Reduced the Risk of Invasive Cancer Returning Compared to Herceptin and Chemotherapy in HER2-Positive Early Breast Cancer gene.com ↗
At three years, 94.1 percent of people treated with the Perjeta-based regimen did not have their breast cancer return compared to 93.2 percent treated with Herceptin and chemotherapy. |
| 2017-05-10 | Genentech, Inc. | Results Genentech to Present New Data on Personalized Medicines and Cancer Immunotherapies at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting gene.com ↗
New pivotal results for Perjeta® (pertuzumab) and Alecensa® (alectinib) demonstrating improvement over standards of care |
| 2017-03-02 | Hoffmann-La Roche | Results Phase III APHINITY study shows Roche’s Perjeta® regimen helped people with an aggressive type of early breast cancer live longer without their disease returning compared to Herceptin® and chemotherapy roche.com ↗
The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone. |
| 2017-03-01 | Genentech, Inc. | Results Phase III APHINITY Study Shows Genentech’s Perjeta® Regimen Helped People with an Aggressive Type of Early Breast Cancer Live Longer without their Disease Returning Compared to Herceptin® and Chemotherapy gene.com ↗
The study met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (EBC) compared to Herceptin and chemotherapy alone. |
| 2015-05-31 | Genentech, Inc. | Results Genentech’s Perjeta Regimen Helped People with HER2-Positive Early Breast Cancer Live Longer without Their Disease Returning or Getting Worse Compared to Herceptin and Chemotherapy gene.com ↗
The results suggested that people who received the Perjeta regimen prior to surgery were 31 percent less likely to experience disease worsening, recurrence or death (PFS HR=0.69; 95% CI, 0.34–1.40) compared to those who received Herceptin and chemotherapy. |
| 2014-12-19 | AbbVie | Results ImmunoGen Reports Roche Has Provided an Update on the MARIANNE Trial abbvie.com ↗
Roche has reported the MARIANNE study showed the three regimens helped people live without their disease worsening (PFS) for a similar amount of time, meeting its non-inferiority endpoint as assessed by an Independent Review Committee. |
All press releases naming this drug 83 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 338 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | pertuzumab | “Patients received neoadjuvant chemotherapy consisting of paclitaxel (80 mg/m2, day 1 and 8 of each 21-day cycle, intravenous), trastuzumab (6 mg/kg on day 1 of each cycle...” PMID 41713473 ↗ Feb 2026324“Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line...” NCT06450314 ↗ “In patients with ER-positive and HER2-positive breast cancer, the therapeutic potential of combining trastuzumab, pertuzumab, and pyrotinib-representing a triple-targeted...” NCT07290166 ↗ “Pertuzumab will be administered as an IV loading dose of 840 milligrams (mg) on day 1 of cycle 1 (1 cycle length = 21 days), and 420 mg Q3W on day 1 of subsequent cycles until...” NCT03811418 ↗ “Perjeta® with the general name Pertuzumab injection, is a recombinant humanized monoclonal antibody targeting the extracellular second domain of human epidermal growth factor...” NCT05985187 ↗ “Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.” NCT06884254 ↗ “Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer” PMID 42150145 ↗ May 2026 “Axitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib” NCT07802418 ↗ “patients will receive pertuzumab (RPH-051 or Perjeta® drug products) combined with trastuzumab and docetaxel according to the following scheme” NCT07386938 ↗ “Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles, administered per USPI (Unites States Prescribing Information) Label” NCT05256745 ↗ “TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen” NCT03387553 ↗ |
| Known as | Combination product: Trastuzumab + Pertuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05132582 ↗ |
| Known as | Omnitarg | “RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2” NCT02490475 ↗ |
| Known as | Perjeta | “This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4(Perjeta) and capecitabine (Xeloda) in participants with advanced solid...” NCT02494596 ↗18“Perjeta® with the general name Pertuzumab injection, is a recombinant humanized monoclonal antibody targeting the extracellular second domain of human epidermal growth factor...” NCT05985187 ↗ “TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen” NCT03387553 ↗ “The other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast cancer.” NCT02252887 ↗ “Pertuzumab (Perjeta®) is a fully humanized monoclonal antibody” NCT05385705 ↗ “pertuzumab [PERJETA™]” NCT00943670 ↗ “Pertuzumab (Perjeta®)” NCT05283837 ↗ “pertuzumab [Perjeta]” NCT02402712 ↗ |
| Known as | Pmab | “Trastuzumab (Tmab), pertuzumab (Pmab), and taxane has been a standard first-line treatment for recurrent or metastatic human epidermal growth factor (HER2)-positive breast...” PMID 32381018 ↗ May 2020 |
| Known as | QL1209 | “QL1209 (Pertuzumab Injection): First dose 840mg, then 420mg, every 3 weeks, for a total of 6 cycles” NCT07299890 ↗ |
| Known as | QL1209 (A pertuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd) | “QL1209 (A pertuzumab biosimilar produced by Qilu Pharmaceutical Co., Ltd)” NCT07187752 ↗ |
| Known as | rhuMAb 2C4 | “A Phase Ib, Open-Label, Multicenter Study of the Safety and Pharmacokinetics of the Combination of RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and...” NCT02494596 ↗7“A Phase II, Open-label, Multicenter Study to Evaluate the Effect of Tumor-based HER2 Activation on the Efficacy of rhuMAb 2C4 (Pertuzumab) in Subjects With Recurrent Non-Small...” NCT00063154 ↗ “An Open-Label, Multicenter Extension Study of Pertuzumab (rhuMAb 2C4) in Subjects Treated With Pertuzumab in a Previous Genentech-Sponsored Phase II Cancer Study” NCT00096941 ↗ “Pertuzumab (rhuMAb 2C4)” NCT00058552 ↗ |
| Known as | ZRC-3277 | “Pertuzumab (ZRC-3277)” NCT05283837 ↗ |
| Action | Inhibit | “Pertuzumab disrupts heterodimerization between human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR), HER3, and HER4.” PMID 28057664 ↗ Apr 2017 |
| Modality | Monoclonal antibody | “rhuMAb 2C4 (Pertuzumab)” NCT00063154 ↗ |
| Route | Intravenous | “Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year” NCT00063154 ↗ |
| Target | ERBB2 | “Pertuzumab, a human epidermal growth factor receptor 2 (HER2) -targeted monoclonal antibody” PMID 20124182 ↗ Feb 2010 |