Clinical TopicsGlobal BulletinAll NewsApproval Alert
2 Minute DrillAround the PracticeBetween the LinesBreaking BarriersFace OffFrom All AnglesMeeting of the MindsMorning RoundsOncViewPodcastsReadout 360Sponsored MediaTraining AcademyTreatment Algorithms with the Oncology Brothers
Conferences
All JournalsEditorial BoardFor AuthorsYear in Review
Frontline ForumSatellite Sessions
CME/CE
Contemporary ConceptsAwareness MonthInteractive ToolsNurse Practitioners/Physician's AssistantsPartnersSponsored
Career CenterSubscribe
Adverse Effects
Biomarkers
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
Hormone-related Cancers
Immunotherapy
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
LymphomaLymphoma
Melanoma
Mesothelioma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
Spotlight -
  • Around the Practice
  • Between the Lines
  • Contemporary Concepts
  • Journal
  • OncView
  • Podcasts
  • Readout 360
  • Insights from Experts at Mayo Clinic on Translating Evidence to Clinical Practice
  • Optimizing Outcomes in Patients with HER2+ Metastatic Breast Cancer
Adverse Effects
Biomarkers
Brain Cancer
Breast CancerBreast CancerBreast Cancer
Gastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal CancerGastrointestinal Cancer
Genitourinary CancersGenitourinary CancersGenitourinary CancersGenitourinary Cancers
Gynecologic CancersGynecologic CancersGynecologic CancersGynecologic Cancers
Head & Neck Cancer
Hematologic OncologyHematologic OncologyHematologic OncologyHematologic Oncology
Hormone-related Cancers
Immunotherapy
InfectionInfection
Leukemia
Lung CancerLung CancerLung Cancer
LymphomaLymphoma
Melanoma
Mesothelioma
Neuroendocrine Tumors
Oncology
Pediatric Cancers
Radiation Oncology
Sarcoma
Screening
Skin Cancer & Melanoma
Surgery
Thyroid Cancer
    • Conferences
    • CME/CE
    • Career Center
    • Subscribe
Advertisement

Zanidatamab Recommended for Conditional Marketing Approval in Advanced HER2+ BTC

April 29, 2025
By Roman Fabbricatore
Fact checked by" Ariana Pelosci
News
Article

The recommendation from the CHMP is based on results from the phase 2b HERIZON-BTC-01 trial of zanidatamab in advanced HER2+ biliary tract cancer.

No deaths were attribute to zanidatamab for patients with advanced HER2+ biliary tract cancer treated in the phase 2b HERIZON-BTC-01 trial.

No deaths were attributed to zanidatamab for patients with advanced HER2+ biliary tract cancer treated in the phase 2b HERIZON-BTC-01 trial.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending a conditional marketing authorization to zanidatamab-hrii (Ziihera) as a monotherapy treatment for adult patients with unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC) previously treated with 1 or more prior lines of systemic therapy, according to a news release from the drug’s developer, Jazz Pharmaceuticals.1

The CHMP recommendation is based on results from the phase 2b HERIZON-BTC-01 (NCT04466891) trial, evaluating zanidatamab in previously treated, inoperable HER2-positive BTC. Results presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting showed zanidatamab elicited an overall response rate (ORR) of 52% (95% CI, 39%-65%) via independent review committee (IRC) assessment.2

Further data revealed that the disease control rate was 68.8% and that the median duration of response (DOR) was 14.9 months (95% CI, 7.4-not reached).3 Furthermore, among patients with immunohistochemistry score of 3+, the median overall survival was 18.1 months (95% CI, 12.2-23.2), with respective 6- and 12-month rates of 90.1% (95% CI, 79.2%-95.4%) and 65.0% (95% CI, 51.6%-75.6%).

Zanidatamab received FDA approval as a 50-mg/mL injection or intravenous infusion for patients with previously treated, unresectable, or metastatic HER2-positive BTC in November 2024.4 Additionally, the FDA granted priority review to a biologics license application for zanidatamab in this patient population based on initial trial findings.5

"This positive CHMP opinion is a welcome step for physicians and patients in Europe who face a critical unmet need in HER2-positive biliary tract cancers, a rare and aggressive group of cancers with poor prognosis and limited treatment options," Robert Iannone, MD, MSCE, executive vice president, global head of research and development, and chief medical officer at Jazz Pharmaceuticals, stated in a news release on the CHMP decision.1 "If approved, zanidatamab would be the first HER2-targeted therapy licensed for this difficult-to-treat cancer in the EU, marking an important milestone in addressing this unmet need. We look forward to the European Commission's decision and the opportunity to provide a new treatment option for patients."

Patients with advanced, unresectable, or metastatic HER2-positive BTC in the phase 2b trial received 20 mg/kg of intravenous zanidatamab every 2 weeks plus infusion-related reaction prophylaxis on days 1 and 15 of 28-day cycles. Additionally, patients underwent CT/MRI per RECIST v1.1 criteria every 8 weeks.

The primary study end point was IRC-confirmed ORR. Secondary end points included DOR, disease control rate (DCR), and progression-free survival (PFS) per IRC as well as investigator-assessed ORR, DOR, DCR, and PFS.

Regarding safety, any-grade treatment-emergent adverse effects (TRAEs) occurred in 96.6% of patients who received zanidatamab in the trial. The most common any-grade TRAEs included diarrhea (36.8%), infusion-related reactions (33.3%), decreased ejection fraction (10.3%), and nausea (9.2%). The most common grade 3 or higher TRAEs included diarrhea (4.6%), decreased ejection fraction (3.4%), anemia (3.4%), and increased aspartate aminotransferase level (2.3%).

No deaths were attributed to zanidatamab treatment. TRAEs leading to dose reductions included one grade 3 instance of diarrhea, individual cases of grade 1 diarrhea and nausea, and one grade 2 instance of decreased weight.

Patients eligible for enrollment were 18 years or older, received prior gemcitabine-containing therapy, had 1 or more measurable target lesions, and had an ECOG performance status of 0 or 1. Patients were ineligible for enrollment if they received prior HER2-targeting therapies.

References

  1. Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2-positive biliary tract cancer. News release. Jazz Pharmaceuticals. April 25, 2025. Accessed April 25, 2025. https://tinyurl.com/235t87us
  2. Pant S, Fan J, Oh DY, et al. Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. J Clin Oncol. 2024;42(suppl 16):4091. doi:10.1200/JCO.2024.42.16_suppl.4091
  3. Harding JJ, Fan J, Oh DY, et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. 2023;24(7):772-782. doi:10.1016/S1470-2045(23)00242-5
  4. 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). News release. Jazz Pharmaceuticals. November 20, 2024. Accessed April 25, 2025. https://shorturl.at/k6u8A
  5. Zanidatamab granted priority review for HER2-positive metastatic biliary tract cancer. News release. Jazz Pharmaceuticals. May 29, 2024. Accessed April 25, 2025. https://tinyurl.com/2py5zj6e
Recent Videos
Testing a patient’s genetics may influence decisions such as using longer courses of radiotherapy, says Rachit Kumar, MD.
Spatial transcriptomics and multiplex immunohistochemistry from samples may elucidate outcomes for patients who undergo surgical care for cancer.
Future work may focus on optimizing symptom management associated with percutaneous transesophageal gastrostomy placement in malignant bowel obstructions.
Post-operative length of stay ranged from 4 to 9 days for patients who underwent percutaneous transesophageal gastrostomy for malignant bowel obstructions.
Treatment with KRAS inhibitors may help mitigate a common driver of genetic alteration across a majority of pancreatic cancers.
Various methods of communication ensure that members from radiation oncology, pathology, and other departments are on the same page regarding treatment.
Updated results from the BREAKWATER study seemed to be most impactful to the CRC space, according to Michael J. Pishvaian, MD, PhD.
Related Content
Advertisement

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Hypofractionated RT Shows Portal Vein Tumor Thrombosis Control, OS in HCC

Roman Fabbricatore
April 29th 2025
Article

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.


The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.

Sotorasib Combo Approval May Address Novel Therapy Need in KRAS G12C+ CRC

Marwan G. Fakih, MD
February 24th 2025
Podcast

The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.


SBRT Shows Positive 3-Year OS Rate in Newly Diagnosed Early-Stage HCC

SBRT Shows Positive 3-Year OS Rate in Newly Diagnosed Early-Stage HCC

Tim Cortese
April 26th 2025
Article

SBRT demonstrated positive 3-year outcomes as a treatment in patients with early-stage HCC based on results from the phase 2 STRSPH trial.


Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.

Educating Patients and Clinicians on End-of-Life Care and Discussions

Kelley A. Rone, DNP, RN, AGNP-c
November 11th 2024
Podcast

Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.


Fruquintinib Combo Exhibits Manageable Safety Profile in Pretreated mCRC

Fruquintinib Combo Exhibits Manageable Safety Profile in Pretreated mCRC

Tim Cortese
April 22nd 2025
Article

Treatment-related adverse events of special interest occurred in 64.9% of patients who received fruquintinib and 23.0% of those who received placebo.


3 Things You Should Know About Advances in Gastroesophageal Adenocarcinoma Therapy

3 Things You Should Know About Advances in Gastroesophageal Adenocarcinoma Therapy

ONCOLOGY Staff
April 17th 2025
Article

Immunotherapy combinations and targeted therapy options may help bridge clinical gaps in early-stage, locally advanced, and metastatic gastroesophageal adenocarcinomas.

Related Content
Advertisement

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.

Hypofractionated RT Shows Portal Vein Tumor Thrombosis Control, OS in HCC

Roman Fabbricatore
April 29th 2025
Article

Ten-fraction image-guided hypofractionated radiation therapy could be a feasible treatment option for portal vein tumor thrombosis in patients with HCC.


The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.

Sotorasib Combo Approval May Address Novel Therapy Need in KRAS G12C+ CRC

Marwan G. Fakih, MD
February 24th 2025
Podcast

The approval of sotorasib plus panitumumab is a “welcome step” in KRAS G12C-mutated colorectal cancer, according to Marwan G. Fakih, MD.


SBRT Shows Positive 3-Year OS Rate in Newly Diagnosed Early-Stage HCC

SBRT Shows Positive 3-Year OS Rate in Newly Diagnosed Early-Stage HCC

Tim Cortese
April 26th 2025
Article

SBRT demonstrated positive 3-year outcomes as a treatment in patients with early-stage HCC based on results from the phase 2 STRSPH trial.


Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.

Educating Patients and Clinicians on End-of-Life Care and Discussions

Kelley A. Rone, DNP, RN, AGNP-c
November 11th 2024
Podcast

Kelley A. Rone, DNP, RN, AGNP-c, provides perspective on approaching end-of-life conversations with patients with GI cancers.


Fruquintinib Combo Exhibits Manageable Safety Profile in Pretreated mCRC

Fruquintinib Combo Exhibits Manageable Safety Profile in Pretreated mCRC

Tim Cortese
April 22nd 2025
Article

Treatment-related adverse events of special interest occurred in 64.9% of patients who received fruquintinib and 23.0% of those who received placebo.


3 Things You Should Know About Advances in Gastroesophageal Adenocarcinoma Therapy

3 Things You Should Know About Advances in Gastroesophageal Adenocarcinoma Therapy

ONCOLOGY Staff
April 17th 2025
Article

Immunotherapy combinations and targeted therapy options may help bridge clinical gaps in early-stage, locally advanced, and metastatic gastroesophageal adenocarcinomas.

Advertisement
About
Advertise
CureToday.com
OncLive.com
OncNursingNews.com
TargetedOnc.com
Editorial
Contact
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.