Pipeline
Our clinical and preclinical pipeline includes wholly owned and partnered therapeutic candidates targeting difficult-to-treat cancers and other serious diseases.
Product Candidate
Preclinical
Phase 1
Phase 2
Pivotal
Partner
ZW171
Phase: Phase 1
ZW171
Advanced or Metastatic Mesothelin-Expressing Cancers
ZW171 is a bispecific antibody designed to enable T cell-mediated tumor cell killing through simultaneous binding to the extracellular domain of mesothelin (MSLN) protein on tumor cells and the engagement of CD3 on T cells. ZW171’s unique 2+1 format and incorporation of a novel low-affinity anti-CD3 binder aims to improve the therapeutic window in patients by limiting on-target, off-tumor effects and cytokine release syndrome (CRS) while maintaining potent anti-tumor activity against MSLN-expressing cancers. By selectively binding to tumors and sparing normal tissues, ZW171 is designed to improve both tolerability and anti-tumor activity against MSLN-expressing cancers. Engineered and optimized using our Azymetric™ and EFECT™4 technologies, ZW171 demonstrates enhanced anti-tumor activity and safety in preclinical models, inducing potent, preferential killing of MSLN-overexpressing cells while mitigating the risk of on-target, off-tumor activity, peripheral T cell activation, and CRS.
ZW171 is projected to enter Phase I clinical trials in the second half of 2024.
Product Status
Indications
- Ovarian cancer
- Non-small cell lung cancer
- Mesothelioma
- Other mesothelin-expressing cancers
Technology
ZW191
Phase: Phase 1
ZW191
Advanced Solid Tumors
ZW191 is an antibody-drug conjugate that is engineered to target a protein called folate receptor-⍺ (FR⍺) found on the surface of a variety of tumors such as on ovarian, endometrial, and lung cancers. ZW191’s differentiated design increases its ability to internalize into FR⍺ -expressing cells. Further, it releases a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill tumor cells.
ZW191 is projected to enter Phase I clinical trials in the second half of 2024.
Product Status
Indications
- Ovarian cancer & gynaecological cancers
- Non-small cell lung cancer
Technology
Preclinical
Product Candidate
ZW251
Phase: Preclinical
ZW251
Glypican-3 Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
ZW251 is the first antibody-drug conjugate engineered to target a protein called glypican-3 (GPC3), which is found on a difficult-to-treat liver cancer, hepatocellular carcinoma (HCC). The antibody is uniquely designed to target and strongly bind to the GPC3 protein, then release a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill the tumor cells.
With promising preclinical tolerability and anti-tumor activity, ZW251 is currently in the IND enabling stage of development and is projected to enter Phase I clinical trials in 2025.
Product Status
Indications
Hepatocellular carcinoma (HCC)
Technology
Product Candidate
ZW220
Phase: Preclinical
ZW220
NaPi2b Targeted Topoisomerase 1 Inhibitor Antibody Drug Conjugate
ZW220 is an antibody-drug conjugate that is engineered to target a protein called sodium-dependent phosphate transporter 2b (NaPi2b) found on the surface of a variety of tumors, such as on ovarian, lung and pancreatic cancers. ZW220 differentiated design optimizes its ability to target and strongly bind to the NaPi2b protein and then effectively internalize into the cell. ZW220 releases a toxic chemotherapy that we developed in-house, a bystander active topoisomerase-1 inhibitor (ZD06519), to kill tumor cells.
With promising preclinical tolerability and anti-tumor activity, ZW220 is currently in the IND- enabling stage of development and is projected to enter Phase I clinical trials in 2025.
Product Status
Indications
- Ovarian cancer
- Non-small cell lung cancer
Technology
Partners
Product Candidate
Zanidatamab
Phase: Pivotal
Partner:
ZIIHERA®(zanidatamab-hrii)
1st-Line Gastroesophageal Adenocarcinomas
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Pivotal
Partner:
ZIIHERA®(zanidatamab-hrii)
2nd-Line Biliary Tract Cancers
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Pivotal
Partner:
ZIIHERA®(zanidatamab-hrii)
1st-Line Gastrointestinal Cancers
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Phase 2
Partner:
ZIIHERA®(zanidatamab-hrii)
Late-Line Breast Cancer
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Pivotal
Partner:
ZIIHERA®(zanidatamab-hrii)
Previously T-DXd Treated HER2+ Breast Cancer
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Phase 2
Partner:
ZIIHERA®(zanidatamab-hrii)
HER2-Expressing Breast Cancer
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Phase: Phase 2
Partner:
ZIIHERA®(zanidatamab-hrii)
Breast Cancer
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
Zanidatamab
Phase: Phase 2
Partner:
ZIIHERA®(zanidatamab-hrii)
HER2+ Advanced Gastroesophageal Adenocarcinoma
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Phase: Phase 1
Partner:
ZIIHERA®(zanidatamab-hrii)
Breast Cancer
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Phase: Phase 1
Partner:
ZIIHERA®(zanidatamab-hrii)
Advanced HER2-Expressing Cancers
Ziihera® (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated 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.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1
Zanidatamab is not approved anywhere else in the world.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.
More information about Ziihera, the Full Prescribing Information, including Boxed Warning and Patient Information, is available here.
1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
Product Status
Indications
- Biliary Tract Cancers
- Breast Cancer
- Gastroesophageal Adenocarcinomas
- Colorectal Cancer
- HER2-Expressing Cancers
Partner
Technology
Product Candidate
JNJ-78278343
Phase: Phase 1
Partner:
JNJ-78278343
(CD3 x KLK2)
Product Status
Indications
- Castration-Resistant Prostate Cancer
Partner
Technology
Product Candidate
Bispecific
Phase: Preclinical
Partner:
Product Candidate
Bispecific
Phase: Preclinical
Partner:
Bispecific
Product Status
Indications
- Immuno-Oncology
Partner
Technology
Product Candidate
Bispecific
Phase: Preclinical
Partner: