Aakash Desai

Aakash Desai: FDA approves a biparatopic, Zanidatamab – targeting HER2 for BTCs

Aakash Desai, Associate Director and Assistant Professor at UAB O’Neal Comprehensive Cancer Center, shared a post on LinkedIn:

“FDA Oncology approves a biparatopic, Zanidatamab – targeting HER2 for biliary tract cancers based on HERIZON-BTC-01!

– ORR: 41.3%, mDOR=14.9 mths
– Approval for IHC 3+, where TDX-d also has agnostic approval
– 18% Gr3 TRAEs, diarrhea.”

Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study

Authors: James J Harding, Jia Fan, Do-Youn Oh, Hye Jin Choi, Jin Won Kim, Heung-Moon Chang, Lequn Bao, Hui-Chuan Sun, Teresa Macarulla, Feng Xie, Jean-Phillippe Metges, Jie’er Ying, John Bridgewater, Myung-Ah Lee, Mohamedtaki A Tejani, Emerson Y Chen, Dong Uk Kim, Harpreet Wasan, Michel Ducreux, Yuanyuan Bao, Lisa Boyken, Jiafang Ma, Phillip Garfin, Shubham Pant

FDA

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Further Reading:

U.S. FDA Approval of Ziihera for the Previously Treated, Unresectable or IHC 3+ Biliary Tract Cancer

 

Aakash Desai cancer Do-Youn Oh Dong Uk Kim Emerson Y Chen FDA Oncology Feng Xie Harpreet Wasan Heung-Moon Chang Hui-Chuan Sun Hye Jin Choi James J. Harding Jean-Phillippe Metges Jia Fan Jiafang Ma Jie'er Ying Jin Won Kim John Bridgewater Lequn Bao Lisa Boyken Michel Ducreux Mohamedtaki A Tejani Myung-Ah Lee OncoDaily Oncology Phillip Garfin Shubham Pant Teresa Macarulla Yuanyuan Bao Zanidatamab