Shots:
- 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| Press Release
Related News:- Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for R/R Acute Leukemia
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