Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer

The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gastroesophageal adenocarcinoma that carry HER2 mutations. The indication allows Ziihera to be given with or without BeOne Medicines' Tevimbra alongside standard chemotherapy.

Analysts at Truist Securities said the approval was expected but welcomed it as a de‑risking event for Jazz's biggest commercial opportunity. They project peak sales of about $2.5 billion, with roughly 90% of that coming from the gastroesophageal market.

Ziihera was initially cleared in November 2024 for biliary tract cancer under the FDA's accelerated pathway. The new label expands its reach into a much larger patient population, positioning Jazz for a significant launch in the gastroesophageal cancer space.