Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)
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- The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status
- Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends on P-III (HERIZON-BTC-302) confirmatory trial of zanidatamab + SoC vs SoC alone in 1L HER2+ BTC
- Zanidatamab is also being studied P-III (HERIZON-GEA-01) trial with CT & with/without tislelizumab for 1L HER2+ GEAs as well as P-III (EmpowHER-303) trial with physician's choice CT HER2+ mBC patients, progressed on or intolerant to trastuzumab deruxtecan
Ref: Jazz Pharmaceuticals | Image: Jazz Pharmaceuticals
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
