Jazz Pharmaceuticals PLC’s shares rose 2.3% on Tuesday after the U.S. Food and Drug Administration approved Ziihera for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA), regardless of PD-L1 status.
The regulator cleared two regimens: Ziihera combined with Tevimbra and chemotherapy for HER2+ IHC 3+ and IHC 2+/ISH+ patients, and Ziihera with chemotherapy for HER2+ IHC 3+ patients. Ziihera is the first bispecific HER2-targeted antibody paired with a PD-1 inhibitor and chemotherapy approved for all HER2-positive advanced GEA patients, according to the company.
Approval was supported by the Phase 3 HERIZON-GEA-01 trial, which showed that Ziihera-containing combinations reduced the risk of disease progression or death by 35% compared with trastuzumab plus chemotherapy. Median progression-free survival extended to 12.4 months versus 8.1 months for the comparator, while median overall survival reached 26.4 months compared with 19.2 months. In the overall HER2-positive population, the combination also reduced the risk of death by 28%.
Approximately 20% of GEA patients have HER2-positive disease, with more than 31,000 new stomach cancer cases diagnosed annually in the United States. The most common adverse reaction reported was diarrhea, which was managed with antidiarrheals and treatment modifications, resulting in few discontinuations of Ziihera.
Jazz Pharmaceuticals’ stock was last trading at $260.16, up $5.69, or 2.24%, following the announcement.
