- Jazz Pharmaceuticals (JAZZ, Financial) receives a positive opinion from the European Medicines Agency's CHMP for zanidatamab.
- If approved, zanidatamab would be the first HER2-targeted therapy for biliary tract cancer in the EU.
- Approximately 12,000 people are diagnosed annually with HER2+ biliary tract cancer across the U.S., Europe, and Japan.
Jazz Pharmaceuticals (JAZZ) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorization for zanidatamab, a bispecific antibody targeting HER2, for the treatment of adults with advanced or metastatic HER2-positive biliary tract cancer. This positive opinion marks a significant regulatory milestone as it precedes the potential European Commission approval.
The recommendation is based on findings from the Phase 2b HERIZON-BTC-01 trial, which evaluated zanidatamab in patients who had previously received systemic therapy. The European Commission is expected to review this recommendation and make a final decision on approval soon. If approved, zanidatamab would become the first HER2-targeted therapy for this rare cancer in the EU.
This development follows the drug's accelerated approval in the U.S. by the FDA under the brand name Ziihera® in November 2024. Given that biliary tract cancers account for less than 1% of all adult cancers globally, with approximately 26% of these being HER2-positive, zanidatamab has the potential to address a significant unmet medical need within this niche market.
Efforts are also underway to validate the clinical benefits of zanidatamab in the ongoing Phase 3 HERIZON-BTC-302 trial, which is critical for continued approval in the United States and possibly other regions pending local regulatory approvals.
