The FDA has approved zanidatamab as a monotherapy for previously treated HER2-positive biliary tract cancer (BTC). The bispecific antibody is the first HER2-targeted treatment with this indication. Zanidatamab binds to HER2 proteins, blocking HER2 signaling and inducing immune responses. The approval was based on a phase 2 trial with a 52% response rate and a 14.9 month duration of response. Common side effects include diarrhea, infusion-related reactions, abdominal pain, and fatigue. Zanidatamab is administered every 2 weeks at 20 mg/kg. Jazz Pharmaceuticals’ application was granted priority review, breakthrough therapy designation, and orphan drug designation. Ongoing trials are testing zanidatamab in combination with standard therapy for other cancers.
Source link
New Agent for Biliary Tract Cancer Approved
