Jazz Pharmaceuticals’ Zanidatamab Secures the CHMP Positive Opinion to Treat HER2+ Biliary Tract Cancer (BTC)
Shots:
- The CHMP has recommended conditional marketing approval of zanidatamab for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer (BTC) adults, who were previously treated with ≥1L of therapy; EC’s potential approval will be valid in 30 EEA states
- Opinion was based on P-IIb (HERIZON-BTC-01) trial to assess anti-tumor activity of zanidatamab alone in HER2+ inoperable & advanced or metastatic BTC
- Zanidatamab received the US FDA’s accelerated approval in Nov 2024 for previously treated BTC based on ORR & duration of response; continued approval depends on confirmation of clinical benefit in the ongoing P-III (HERIZON-BTC-302) trial
Ref: Jazz Pharmaceuticals | Image: Jazz Pharmaceuticals
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
