China’s NMPA Accepts BLA for Zanidatamab in HER2+ Biliary Tract Cancer

China’s NMPA Accepts BLA for Zanidatamab in HER2+ Biliary Tract Cancer

The National Medical Products Administration (NMPA) in China has approved the biologics license application (BLA) for zanidatamab for the treatment of patients with HER2-positive biliary tract cancer. The acceptance of the BLA in China marks a significant milestone in providing targeted treatment options for individuals with this type of cancer. The application was backed by data from the phase 2b HERIZON-BTC-01 trial, where patients who received zanidatamab demonstrated positive outcomes. The median duration of response and progression-free survival were also promising. The CEO of Zymeworks, Kenneth Galbraith, expressed gratitude to all stakeholders involved in achieving this milestone.

In addition to the acceptance in China, zanidatamab is also being reviewed by the FDA for the treatment of previously treated, unresectable, HER2-positive biliary tract cancer. The ongoing phase 3 trials for zanidatamab in other cancers show potential for its use in various HER2-expressing cancers.

The HERIZON-BTC-01 study was a global effort that examined the use of zanidatamab in patients with HER2-positive biliary tract cancer. The study showed positive results in terms of response rates and disease control. The safety profile of zanidatamab was also favorable, with manageable adverse effects reported.

Collaboration between Zymeworks and BeiGene has been instrumental in advancing the development of zanidatamab. The companies aim to make impactful cancer treatments more accessible to patients worldwide. The acceptance of the BLA in China is a significant step towards achieving this goal.

Reference:
– Zymeworks announces China NMPA acceptance of biologics license application for zanidatamab for second-line treatment of biliary tract cancer. News release. Zymeworks Inc. June 10, 2024. Accessed June 10, 2024. [Link to Source]