AstraZeneca gets CDSCO panel nod to study anticancer drug Datopotamab deruxtecan
New Delhi: Pharmaceutical major, AstraZeneca has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct Phase III clinical trial of the 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,
At the recent SEC meeting for oncology and hematology held on December 9th 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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