New Delhi: Pharmaceutical major, AstraZeneca has received the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of the anticancer drug Datopotamab deruxtecan.

This came after the drug company AstraZeneca presented Phase III clinical trial protocol no. D926NC, version 1.0 dated July 15, 2022, and local clinical trial protocol addendum IND-1, version 1.0 dated August 11, 2022, before the committee.

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Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing promise as a treatment for relapsed or refractory advanced triple-negative breast cancer.

A humanized anti-Trop-2 IgG1 monoclonal antibody is attached to a topoisomerase 1 inhibitor payload via a tetrapeptide-based cleavable linker to form the three parts of the antibody-drug conjugate known as datopotamab deruxtecan.

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It was designed with these key attributes:

- Topoisomerase 1 inhibition as the payload mechanism of action;

- A payload with high potency, short systemic half-life, and stable linker;

- Optimized drug-to-antibody ratio;

- Tumour-selective cleavable linker;

- Bystander antitumor effect.

At the recent SEC meeting for oncology and hematology held on December 9, 2022, the expert panel reviewed the Phase III clinical trial protocol of the anticancer drug Datopotamab Deruxtecan (Dato-DXD).

After detailed deliberation, the committee recommended the grant of permission to conduct the study of the anticancer drug Datopotamab deruxtecan.

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