Memorial Sloan Kettering Cancer Center

FDA granted accelerated approval to zanidatamab (Ziihera®) for advanced bile duct and other HER2-high biliary tract cancers resistant to chemotherapy. Co-led by Dr. James Harding, the clinical trial showed 41.3% objective responses and 18% significant side effects. Zanidatamab, a bispecific antibody, targets HER2 in two places, blocking growth signals and degrading the protein, also alerting the immune system. Rob, a trial participant, saw his cancer shrink and later switched to trastuzumab deruxtecan, showing no signs of disease.

Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) receives FDA accelerated approval for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, becoming the first dual HER2-targeted bispecific antibody treatment. Produced via recombinant DNA technology in Chinese hamster ovary cells, Ziihera's recommended dose is 20 mg/kg every two weeks, with pre-treatment to avoid infusion reactions. Based on the HERIZON-BTC-01 trial, 52% of patients saw improvements, with a median duration of response of 14.9 months. Ongoing phase 3 trials explore Ziihera's effectiveness in combination with standard-of-care therapy and other cancer types.

FDA approves Ziihera, a dual HER2-targeted bispecific antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% objective response rate and 14.9-month median duration of response in the HERIZON-BTC-01 trial. Ziihera's approval may be contingent on verification in the ongoing HERIZON-BTC-302 trial.

The FDA approved zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% objective response rate. Manufactured by Zymeworks Inc. and Jazz Pharmaceuticals, zanidatamab showed antitumor activity in the HERIZON-BTC-01 trial. Common adverse reactions included diarrhea, infusion-related reaction, abdominal pain, and fatigue.

The FDA granted accelerated approval to zanidatamab-hrii for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% overall response rate in the HERIZON-BTC-01 trial. This marks the first dual HER2-targeted, chemotherapy-free treatment for this condition.

SOPHiA GENETICS launches MSK-IMPACT® powered with SOPHiA DDM™, enabling global access to Memorial Sloan Kettering Cancer Center's comprehensive genomic profiling on the SOPHiA DDM™ Platform, enhancing precision oncology analysis and democratizing data-driven medicine.

The FDA granted accelerated approval to Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer, offering a chemotherapy-free option. The approval is based on the Phase IIb HERIZON-BTC-01 trial, showing a confirmed objective response rate of 41.3% and a disease control rate of 68.8%.

FDA approves zanidatamab-hrii (Zihera) for previously treated unresectable or metastatic HER2-positive biliary tract cancer, based on HERIZON-BCT-01 trial results showing 52% ORR and median response duration of 14.9 months.