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Disitamab Vedotin: First Approval.

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

|October 18, 2021

Summary

This summary is machine-generated.

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.

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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.

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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.