Drugs / Zanidatamab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed biliary tract cancer 7 milestones | |||||
| Filed | China (NMPA) | — | biliary tract cancer | 2024-11-05 | “A BLA for zanidatamab in second-line BTC was accepted for review by the Center for Drug Evaluation of the National Medical Products Administration in China in 2024” zymeworks.com ↗ |
| Filed | US (FDA) | — | biliary tract cancer | 2024-10-31 | “Our partner Jazz Pharmaceuticals has submitted a New Drug Application for zanidatamab, the late-stage HER2-targeting bispecific antibody to the FDA” zymeworks.com ↗ |
| Filed | China (NMPA) | — | biliary tract cancer | 2024-08-07 | “BLA accepted by the NMPA for zanidatamab for the treatment of second-line biliary tract cancer” beonemedicines.com ↗ |
| Filed | China (NMPA) | — | biliary tract cancer | 2024-06-10 | “in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC.” zymeworks.com ↗ |
| Filed | US (FDA) | — | biliary tract cancer | 2024-05-29 | “In 2Q24, the U.S. FDA accepted and granted Priority Review of the Biologics License Application for zanidatamab” jazzpharma.com ↗ “FDA has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab” jazzpharma.com ↗ |
| Filed | US (FDA) | — | biliary tract cancer | 2024-03-06 | “A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the HER2-targeted bispecific antibody zanidatamab as a...” zymeworks.com ↗ “Initiation of rolling biologics license application (BLA) filing with the FDA for zanidatamab as second-line treatment for biliary tract cancers (BTC)” zymeworks.com ↗ “In April 2024 , our partner Jazz announced the completion of the rolling BLA submission to the FDA seeking accelerated approval for zanidatamab” zymeworks.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab” jazzpharma.com ↗ “In 2Q24, the U.S. FDA accepted and granted Priority Review of the Biologics License Application for zanidatamab” jazzpharma.com ↗ |
| Filed | EU (EMA) | — | biliary tract cancer | — | “The European Medicines Agency validated the marketing authorization application for zanidatamab in second-line BTC in 2024” zymeworks.com ↗ “Marketing Authorization Application for zanidatamab which was recently submitted to the European Medicines Agency” jazzpharma.com ↗ “In July, our partner Jazz announced that the EMA validated the MAA for zanidatamab in 2L BTC.” zymeworks.com ↗ |
| Filed gastroesophageal adenocarcinoma 2 milestones | |||||
| Filed | China (NMPA) | ZIIHERA | gastroesophageal adenocarcinoma | 2026-05-06 | “BeOne also received acceptance for the filing of the sBLA for zanidatamab by the Center for Drug Evaluation of the China National Medical Products” zymeworks.com ↗ “Received acceptance of sBLA by the CDE in China for the treatment of adult patients with first-line HER2-positive GEA” beonemedicines.com ↗ |
| Filed | US (FDA) | Ziihera | gastroesophageal adenocarcinoma | 2026-04-27 | “FDA accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera ® (zanidatamab-hrii) containing combinations for the first-line...” jazzpharma.com ↗ “Jazz announced U.S. FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally...” zymeworks.com ↗ “A supplemental biologics license application for zanidatamab is under FDA Real-Time Oncology Review in first-line HER2+ locally advanced or metastatic GEA.” jazzpharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Ziihera | — | 2025-06-27 | europa.eu ↗ |
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02892123 | Sep 2016 → Oct 2024 | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07494448 | Jul 2026 → Dec 2027 expected | HER2 positive breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07477444 | Jun 2026 → Jun 2028 expected | gastroesophageal cancer | Universitaire Ziekenhuizen KU Leuven | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05868226 | Feb 2023 → Dec 2030 expected | HER2 positive breast carcinoma, colon adenocarcinoma, hormone receptor-positive breast cancer, metastatic malignant neoplasm +2 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05027139 | Sep 2021 → Aug 2025 | carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT04276493 | Mar 2020 → Dec 2023 | breast cancer, gastric cancer, gastroesophageal cancer | BeiGene | Completed | No outcome recorded |
| Phase 219 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07841873 | Nov 2026 → Jun 2028 expected | biliary tract cancer | Anhui Provincial Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07290985 | Jul 2026 → Jun 2028 expected | gastroesophageal adenocarcinoma | American Association for Cancer Research | Recruiting | No outcome recorded |
| Phase 2 | NCT07685704 | Jul 2026 → Jun 2028 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Zhifeng Zhao, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07631871 | Jun 2026 → Dec 2029 expected | colorectal neoplasm, endometrium neoplasm, head and neck neoplasm, ovarian neoplasm +3 | Haihua Yuan | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405476 | Apr 2026 → Dec 2028 expected | colon carcinoma, rectal carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT07176312 | Jan 2026 → Mar 2029 expected | gastroesophageal adenocarcinoma, metastatic carcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07243938 | Jan 2026 → Jul 2028 expected | gastroesophageal junction adenocarcinoma, rectal carcinoma | Tao Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07273981 | Jan 2026 → Jun 2028 expected | gastroesophageal junction adenocarcinoma | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07192068 | Oct 2025 → Mar 2028 expected | colorectal carcinoma, endometrial cancer, head and neck cancer, non-small cell lung carcinoma +1 | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT07296705 | Oct 2025 → Dec 2027 expected | urinary bladder carcinoma | Fujian Medical University Union Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06695845 | Jan 2025 → Dec 2026 expected | HER2 positive breast carcinoma, colorectal cancer, endometrial cancer, esophageal cancer +7 | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06043427 | Apr 2024 → Jun 2026 overdue | gastroesophageal adenocarcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05270889 | Apr 2022 → Jun 2024 | — | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT05035836 | Nov 2021 → Dec 2028 expected | HER2 positive breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04466891 | Oct 2020 → Jul 2023 | digestive system carcinoma | Jazz Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT04513665 | Aug 2020 → Mar 2024 | endometrial cancer, uterine carcinosarcoma | Memorial Sloan Kettering Cancer Center | Completed | Missed primary |
| Phase 2 | NCT04224272 | Jun 2020 → Apr 2023 | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03929666 | Aug 2019 → Aug 2025 | gastroesophageal adenocarcinoma | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06435429 | Aug 2024 → Apr 2028 expected | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06282575 | Jul 2024 → Dec 2028 expected | biliary tract cancer | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05615818 | Jul 2024 → Jun 2027 expected | biliary tract neoplasm | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05152147 | Dec 2021 → Jul 2026 overdue | esophageal adenocarcinoma, gastric neoplasm, gastroesophageal adenocarcinoma | Jazz Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04164199 | Dec 2019 → May 2026 | cancer | BeOne Medicines | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04578444 | — | carcinoma | Jazz Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT06253871 Background | Mar 2024 → Dec 2027 expected | HER2 positive breast carcinoma, gastroesophageal cancer, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma +1 | Iambic Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06324357 Background | Jun 2024 → Jan 2029 expected | breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 2 | NCT07102381 Comparator | Sep 2025 → Jan 2028 expected | HER2 positive breast carcinoma | Jazz Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | BeOne Medicines | Results BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer beonemedicines.com ↗
At IA2, ZIIHERA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with trastuzumab plus chemotherapy, meeting the remaining primary endpoint analysis of the study. |
| 2026-08-31 | Jazz Pharmaceuticals | Results Ziihera® (zanidatamab-hrii) plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Versus Trastuzumab plus Chemotherapy in First-Line HER2+ Advanced GEA jazzpharma.com ↗
The Ziihera plus chemotherapy OS hazard ratio improved compared with the first interim analysis. |
| 2026-08-25 | Zymeworks BC Inc. | Regulatory U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma zymeworks.com ↗
U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma |
| 2026-08-25 | BeOne Medicines | Regulatory BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA beonemedicines.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy |
| 2026-08-25 | Jazz Pharmaceuticals | Regulatory U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma jazzpharma.com ↗ |
| 2026-05-27 | BeOne Medicines | Results BeOne Medicines Announces Phase 3 HERIZON-GEA Data Published in NEJM and Presented at ASCO 2026 beonemedicines.com ↗
TEVIMBRA plus ZIIHERA and chemotherapy demonstrated statistically significant overall survival benefit with an unprecedented seven-month improvement in first-line HER2+ GEA |
| 2026-05-27 | Jazz Pharmaceuticals | Results Phase 3 HERIZON-GEA-01 Results Published in The New England Journal of Medicine Show Durable and Consistent Survival Benefit with Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA jazzpharma.com ↗
The manuscript builds on the late-breaking oral presentation of the HERIZON-GEA-01 trial results at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI), where zanidatamab-containing combinations demonstrated unprecedented progression-free survival (PFS) and overall survival (OS) outcomes in a global Phase 3 trial. |
| 2026-05-21 | BeOne Medicines | Results BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts beonemedicines.com ↗
TEVIMBRA in combination with ZIIHERA and chemotherapy demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with HER2+ gastroesophageal adenocarcinoma |
| 2026-04-29 | BeOne Medicines | Regulatory U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA beonemedicines.com ↗
The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication. |
| 2026-04-27 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental Biologics License Application for Ziihera® (zanidatamab-hrii) Combinations in First-Line HER2+ Locally Advanced or Metastatic GEA jazzpharma.com ↗
the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera ® (zanidatamab-hrii) |
| 2026-03-18 | Zymeworks BC Inc. | Results Zymeworks Announces Presentations for Ziihera® (zanidatamab-hrii) at 2026 AACR Annual Meeting zymeworks.com ↗
At six weeks, zanidatamab treatment resulted in a statistically significant decrease in tumor size and volume from baseline, and 30% of patients (n=6) achieved pathologic complete response (pCR). |
| 2026-03-18 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Compelling Clinical and Pre-Clinical Data Advancing Oncology Research at AACR 2026 jazzpharma.com ↗
At six weeks, zanidatamab treatment resulted in a statistically significant decrease in tumor size and volume from baseline, and 30% of patients (n=6) achieved pathologic complete response (pCR). |
| 2026-01-06 | Zymeworks BC Inc. | Results Ziihera® (zanidatamab-hrii) Combinations Achieve Unprecedented Results in First-Line HER2+ Locally Advanced or Metastatic GEA including more than Two Years Median Overall Survival Benefit zymeworks.com ↗
Positive results from Phase 3 HERIZON-GEA-01 results support Ziihera as the HER2-targeted agent-of-choice in HER2+ first-line metastatic GEA and Ziihera plus chemotherapy to replace trastuzumab as the new standard of care, with or without tislelizumab regardless of PD-L1 status |
| 2026-01-06 | BeOne Medicines | Results ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA beonemedicines.com ↗
HERIZON-GEA-01 met the dual primary endpoint of progression-free survival (PFS), demonstrating statistically significant and clinically meaningful improvements in both experimental arms compared to the control arm. |
| 2026-01-06 | Jazz Pharmaceuticals | Results Ziihera® (zanidatamab-hrii) Combinations Achieve Unprecedented Results in First-Line HER2+ Locally Advanced or Metastatic GEA Including More Than Two Years Median Overall Survival Benefit jazzpharma.com ↗
Ziihera plus tislelizumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of more than two years |
| 2025-11-17 | Zymeworks BC Inc. | Results Zymeworks Announces Positive HERIZON-GEA-01 Phase 3 Results Supporting Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma zymeworks.com ↗
Ziihera® plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis |
| 2025-11-17 | BeOne Medicines | Results Positive Phase 3 Results Support ZIIHERA® as HER2-Targeted Therapy-of-Choice and Combination with TEVIMBRA® and Chemotherapy as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma beonemedicines.com ↗
Both ZIIHERA plus TEVIMBRA and chemotherapy and ZIIHERA plus chemotherapy demonstrated clinically meaningful and highly statistically significant improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy. |
| 2025-11-17 | Jazz Pharmaceuticals | Results Positive HERIZON-GEA-01 Phase 3 Results Support Ziihera® (zanidatamab-hrii) as HER2-Targeted Agent-of-Choice and Ziihera Combination Regimens as New Standard of Care in First-Line HER2-Positive Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma jazzpharma.com ↗
Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy. |
| 2025-07-01 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer jazzpharma.com ↗
Ziihera is the first HER2-targeted therapy given conditional authorization for HER2-positive BTC in the European Union (EU). |
| 2025-06-02 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Reports Clinically Meaningful Long-Term Median Overall Survival Data for Ziihera® (zanidatamab-hrii) in First-Line HER2-Positive Metastatic Gastroesophageal Adenocarcinoma at ASCO 2025 jazzpharma.com ↗
Among all 46 patients in the study with HER2-expressing mGEA, median PFS was 12.5 months [95% CI: 8.2, 21.8], and median OS also reached 36.5 months [95% CI: 23.6, NE], with the longest observed survival at 57.9 months (censored at data cutoff). |
| 2025-05-30 | Zymeworks BC Inc. | Regulatory Zymeworks Announces NMPA Approval of Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic HER2-high expression (IHC3+) Biliary Tract Cancer zymeworks.com ↗ |
| 2025-04-25 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Receives CHMP Positive Opinion for Zanidatamab for the Treatment of Advanced HER2-Positive Biliary Tract Cancer jazzpharma.com ↗
The CHMP recommendation is based on data from the Phase 2b HERIZON-BTC-01 trial, which evaluated zanidatamab in previously treated, inoperable, and advanced or metastatic HER2-positive BTC. |
| 2025-04-23 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Showcases Transformative Data at ASCO 2025, Highlighting Advances in Small Cell Lung Cancer, HER2+ Gastroesophageal Cancer and Diffuse Glioma jazzpharma.com ↗
Long-term outcomes and survival data for Ziihera ® (zanidatamab-hrii) highlight its potential to reshape the treatment paradigm for newly diagnosed HER2+ gastroesophageal cancer patients |
| 2024-11-21 | Zymeworks BC Inc. | Regulatory FDA Grants U.S. Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) zymeworks.com ↗
FDA Grants U.S. Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) |
| 2024-11-20 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC) jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera ® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. |
| 2024-09-16 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Updated Phase 2 Data for Zanidatamab Demonstrating Increased mPFS in HER2-Positive Metastatic Gastroesophageal Adenocarcinoma at ESMO 2024 jazzpharma.com ↗
Data from 41 patients with HER2-positive mGEA who were treated with zanidatamab in combination with physician's choice of chemotherapy treatment demonstrated a mPFS of 15.2 [95% CI: 9.5, 33.4] months. |
| 2024-09-09 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Advancements in Solid Tumor Oncology Research at ESMO 2024 jazzpharma.com ↗
Additional data from a Phase 2 study evaluating zanidatamab in combination with chemotherapy and bevacizumab as first-line treatment in HER2-positive metastatic colorectal cancer demonstrating encouraging antitumor activity will be presented as a mini-oral presentation at the congress. |
| 2024-06-10 | Zymeworks BC Inc. | Regulatory Zymeworks Announces China NMPA Acceptance of Biologics License Application for Zanidatamab for Second-Line Treatment of Biliary Tract Cancer zymeworks.com ↗
Zymeworks Announces China NMPA Acceptance of Biologics License Application for Zanidatamab for Second-Line Treatment of Biliary Tract Cancer |
| 2024-06-01 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Overall Survival and Longer Follow-Up Data from HERIZON-BTC-01 Trial Evaluating Zanidatamab in Previously Treated HER2-Positive Biliary Tract Cancer at ASCO 2024 jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced long-term follow-up results, including the first-ever overall survival (OS) findings, from the Phase 2b HERIZON-BTC-01 clinical trial of zanidatamab in previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). |
| 2024-05-29 | Jazz Pharmaceuticals | Regulatory Zanidatamab Granted Priority Review for HER2-Positive Metastatic Biliary Tract Cancer jazzpharma.com ↗ |
| 2024-04-02 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Completes Zanidatamab Biologics License Application for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the HER2-targeted bispecific antibody zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). |
| 2023-12-08 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer jazzpharma.com ↗
First presentation of progression-free survival (PFS) primary endpoint data show zanidatamab plus palbociclib and fulvestrant demonstrated a PFS of 67% at 6 months and a median PFS of 12 months in patients with heavily pre-treated HER2+/HR+ metastatic breast cancer (mBC) |
| 2023-06-02 | Zymeworks BC Inc. | Results Jazz Pharmaceuticals and Zymeworks Present Positive Pivotal Phase 2b Trial Data at ASCO 2023 Evaluating Zanidatamab in HER2-Amplified Biliary Tract Cancers zymeworks.com ↗ |
| 2023-06-02 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals and Zymeworks Present Positive Pivotal Phase 2b Trial Data at ASCO 2023 Evaluating Zanidatamab in HER2-Amplified Biliary Tract Cancers jazzpharma.com ↗ |
| 2023-04-18 | Zymeworks BC Inc. | Results Zymeworks Presents New Data from Multiple Preclinical and Clinical Development Programs at the 2023 American Association for Cancer Research Annual Meeting zymeworks.com ↗
ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers |
| 2023-01-19 | Zymeworks BC Inc. | Results Jazz Pharmaceuticals and Zymeworks Announce 84% Overall Survival at 18 Months from Phase 2 Trial Evaluating Zanidatamab in HER2-Expressing Metastatic Gastroesophageal Adenocarcinoma zymeworks.com ↗
The 18-month overall survival rate was 84% [95% confidence interval (CI): 68%, 93%]. |
| 2023-01-19 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals and Zymeworks Announce 84% Overall Survival at 18 Months from Phase 2 Trial Evaluating Zanidatamab in HER2-Expressing Metastatic Gastroesophageal Adenocarcinoma jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Zymeworks Inc. (Nasdaq: ZYME) today announced tolerability and efficacy results, including the first overall survival (OS) data, from a Phase 2 trial examining zanidatamab, an investigational HER2-targeted bispecific antibody, in combination with chemotherapy, in first-line patients with HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA). |
| 2022-12-19 | Zymeworks BC Inc. | Results Zymeworks Announces Positive Topline Data in the Pivotal HERIZON-BTC-01 Trial of Zanidatamab zymeworks.com ↗
Zymeworks Inc. (NASDAQ: ZYME), a clinical-stage biotechnology company developing multifunctional biotherapeutics, today announced positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in patients with previously treated HER2-amplified and expressing BTC. |
| 2022-11-21 | Zymeworks BC Inc. | Results Zymeworks Announces Abstract For Zanidatamab In Late-Line HER2-Positive Hormone-Receptor Positive (HR+) Metastatic Breast Cancer At The San Antonio Breast Cancer Symposium (SABCS) zymeworks.com ↗
The confirmed objective response rate was 34.5% and the disease control rate was 93.1% in 29 response-evaluable patients. |
| 2022-05-26 | Zymeworks BC Inc. | Results Clinical Data Demonstrating Promising Antitumor Activity with Zanidatamab in 1L Setting of HER2‑Positive Breast and Gastroesophageal Cancers to be Presented at ASCO 2022 zymeworks.com ↗
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, today announced new clinical data for the HER2‑targeted bispecific antibody zanidatamab in both HER2-positive breast cancer and gastric/gastroesophageal junction adenocarcinoma. |
All press releases naming this drug 57 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zanidatamab | “IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR...” NCT06253871 ↗33“Zanidatamab (ZW25), a humanized, bispecific antibody that simultaneously binds the 2 distinct HER2 epitopes bound by trastuzumab and pertuzumab, has demonstrated safety and...” PMID 38262242 ↗ Jan 2024 “Zanidatamab, a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody” PMID 40473445 ↗ Jun 2025 |
| Known as | Zanidatamab-hrii | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650256 ↗ |
| Known as | Ziihera | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650256 ↗ |
| Known as | ZW25 | “This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents...” NCT02892123 ↗3“ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.” NCT04224272 ↗ |
| Action | Deplete | “Zanidatamab is an antibody designed to destroy cancer cells that have higher-than-normal HER2 protein or gene levels.” PMID 39114870 ↗ Aug 2024 |
| Modality | Monoclonal antibody | “Zanidatamab is a humanised, bispecific monoclonal antibody directed against two non-overlapping domains of HER2.” PMID 36400106 ↗ Nov 2022 |
| Route | Intravenous | “Zanidatamab: IV Infusion” NCT01042379 ↗ |
| Target | ERBB2 | “Zanidatamab is a humanised, bispecific monoclonal antibody directed against two non-overlapping domains of HER2.” PMID 36400106 ↗ Nov 2022 |