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Disitamab Vedotin: First Approval
1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|October 18, 2021
Summary
Disitamab vedotin, an antibody-drug conjugate targeting HER2, has gained its first approval in China for advanced gastric cancer. This marks a significant milestone for the treatment of HER2-overexpressing solid tumors.
Area of Science:
- Oncology
- Pharmacology
- Biotechnology
Background:
- Disitamab vedotin is an antibody-drug conjugate targeting HER2.
- It combines a monoclonal antibody with a cytotoxic agent, monomethyl auristatin E.
- Developed by RemeGen and Seagen, it targets solid tumors, including gastric cancer.
Purpose of the Study:
- To summarize the development milestones of disitamab vedotin.
- To highlight its first Biologics License Application (BLA) approval in China.
- To detail its application in treating HER2-overexpressing locally advanced or metastatic gastric cancer.
Main Methods:
- Development of disitamab vedotin as an antibody-drug conjugate.
- Clinical trials for HER2-overexpressing solid tumors.
- Regulatory submission and approval process.
Main Results:
- Disitamab vedotin received BLA approval in China in June 2021.
- Approval is for patients with HER2-overexpressing locally advanced or metastatic gastric cancer.
- The drug is also under development for urothelial, biliary tract, non-small cell lung, and breast cancers.
Conclusions:
- Disitamab vedotin's first approval represents a key advancement in HER2-targeted therapy.
- This milestone paves the way for broader applications in various solid tumors.
- Further clinical development is ongoing globally.
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