Zanidatamab Gets FDA Breakthrough Designation for HER2 Gene–Amplified Biliary Tract Cancer

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The FDA has granted a breakthrough therapy designation to zanidatamab for the treatment of patients with HER2 gene–amplified biliary tract cancer who have received prior therapy.

The FDA has granted a breakthrough therapy designation to zanidatamab for the treatment of patients with HER2 gene—amplified biliary tract cancer (BTC) who have received prior therapy. The designation is based on an ongoing phase 1 study (NCT02892123) of zanidatamab in patients with locally advanced, unresectable and/or metastatic HER2-expressing cancers, including BTC. Findings from the trial will be presented at the 2021 Gastrointestinal Cancers Symposium in January.

"This breakthrough therapy designation from the FDA, based on data generated in BTC patients treated in the initial phase 1 trial, is recognition of the potential of zanidatamab to provide a new approach to cancer treatment," said Diana Hausman, MD, chief medical officer at Zymeworks, the developer of zanidatamab. "This milestone supports our strategy for accelerated approval and will help make zanidatamab available for patients as quickly as possible."

BTC comprises approximately 3% of all adult cancers and are linked with a poor prognosis. On an international scale, 210,000 people are diagnosed with BTC annually. Additionally, at least 65% of BTCs, when diagnosed, cannot be surgically resected and those that are typically have a high recurrence rate. Current systemic options are limited for those who progress on first-line chemotherapy.

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