FDA Approves Ziihera in First-Line HER2+ GEA, Establishing New Standard of Care
JAZZ has more than doubled off its 52-week low of $122.5.
Summary
The FDA approved Ziihera (zanidatamab-hrii) for first-line treatment of HER2+ gastroesophageal adenocarcinoma, both with and without tislelizumab plus chemotherapy. This is a major label expansion from its prior biliary tract cancer indication. The approval is based on the Phase 3 HERIZON-GEA-01 trial, which showed a median overall survival of 26.4 months versus 19.2 months for trastuzumab plus chemotherapy, a 28% reduction in risk of death. Ziihera is now the first bispecific HER2-targeted antibody combined with a PD-1 inhibitor approved for all HER2+ advanced GEA patients regardless of PD-L1 status. This follows the recent Q2 earnings where Ziihera generated $15.4M in sales for biliary tract cancer, and the company will host an investor webcast today at 4:30 p.m. ET to discuss the approval. The approval significantly expands the addressable patient population and establishes a new standard of care in a disease with poor outcomes.
At the time of this announcement, JAZZ was trading at $254.99 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $16.6B. The 52-week trading range was $122.50 to $265.05. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: PR Newswire.