Zymeworks Reports the NMPA’s BLA Acceptance of Zanidatamab to Treat Biliary Tract Cancer
Shots:
- The NMPA has accepted the BLA of zanidatamab as a 2L treatment of HER2+ biliary tract cancer. BLA for the same has also been accepted by the US FDA and granted with priority review with the decision anticipated on Nov 29, 2024
- The BLA was supported by the P-IIb (HERIZON-BTC-01) trial assessing the safety & efficacy of zanidatamab to treat unresectable, locally advanced, or metastatic HER2+ BTC. Results as of Oct 2022, published in Lancet Oncology, showed 41.3% ORR, 12.9mos. mDoR & 5.5mos. mPFS
- Furthermore, Zymeworks will receive $8M milestone for the BLA accpetance, as per Asia Pacific license and collaboration agreement with BeiGene, and will further receive additional $164M milestones & sales-based royalties across the Asia Pacific region
Ref: Zymeworks | Image: Zymeworks
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
