AstraZeneca gets CDSCO panel nod to study anticancer drug Datopotamab deruxtecan

This came after the drug major AstraZeneca presented Phase III clinical trial protocol no D926NC, version 1.0 dated 15-07-2022, local clinical trial protocol addendum IND-1, version 1.0 dated 11-08-2022 before the committee.

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.

Datopotamab deruxtecan is an antibody-drug conjugate with three components: a humanized anti–Trop-2 IgG1 monoclonal antibody attached to a topoisomerase 1 inhibitor payload via a tetrapeptide-based cleavable linker. 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; and bystander antitumor effect,

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

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