Sierra Oncology, Inc.

Zymeworks' Zanidatamab (Ziihera) Receives FDA Approval for HER2-Positive Biliary Tract Cancer

6 months ago

• Zymeworks' partnered drug, zanidatamab (now Ziihera), has gained FDA approval for treating HER2-positive metastatic biliary tract cancer (BTC). • This marks the first bispecific antibody and chemotherapy-free option for this rare and aggressive cancer, affecting approximately 16,000 new patients annually in the US. • The approval triggers a $25 million milestone payment to Zymeworks from Jazz Pharmaceuticals, with potential for further payments based on regulatory and commercial success. • Zanidatamab is also being investigated for other cancers, including gastric cancer, with potential peak sales reaching up to $2 billion across various indications.