Zanidatamab

The FDA approved zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2+ biliary tract cancer, based on the phase 2b HERIZON-BTC-01 trial showing a 52% ORR and 14.9-month median DOR. This marks the first HER2-targeted treatment for this condition.

FDA grants accelerated approval to Zymeworks' Ziihera for bilary tract cancer, triggering $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a bispecific antibody variant of Zanidatamab, developed for various cancers.

FDA approves Jazz Pharmaceuticals' Ziihera (zanidatamab), the first dual HER2-targeted bispecific antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, administered every two weeks.

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.

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.

FDA granted accelerated approval to zanidatamab-hrii (Ziihera) for HER2-positive biliary tract cancer. Efficacy showed 52% response rate in a trial of 62 patients. Companion diagnostic Ventana PATHWAY anti-HER-2/neu (4B5) was also approved. Zanidatamab carries a boxed warning for embryofetal toxicity and common adverse reactions include diarrhea and fatigue. The drug is administered at 20 mg/kg every 2 weeks.

FDA grants accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer. HERIZON-BTC-01 trial data showed 52% ORR and 14.9-month median duration of response. Zanidatamab is the first dual HER2-targeted, chemotherapy-free treatment for this condition.

Zymeworks Inc. announces participation in upcoming investor conferences and Research & Development Day, featuring updates on preclinical programs and therapeutic platform expansions.

The FDA granted accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2+ biliary tract cancer, showing positive ORR and DOR. Continued approval depends on clinical benefits in the HERIZON-BTC-302 trial. Zanidatamab is also under investigation for other tumor types. The HERIZON-BTC-01 trial reported a 52% ORR and median DOR of 14.9 months, with serious AEs in 53% of patients.