CDSCO approves AstraZeneca Anticancer Drug Trastuzumab Deruxtecan Protocol Amendment
New Delhi: Based on the justification provided by the pharma major AstraZeneca, the Subject Expert Committee(SEC) functional under Central Drug Standard Control Organization(CDSCO) has approved the protocol amendment proposal for anticancer drug Trastuzumab Deruxtecan (T-DXd), which is an antibody used to treat certain types of unresectable or metastatic HER-2 positive breast cancer..
Trastuzumab deruxtecan is a humanized anti-HER2 IgG1 antibody, targeting cancer cause by mutation of the HER2 gene. In addition, the small molecule portion of this drug, deruxtecan (DXd), is a topoisomerase I inhibitor.It is attached to the antibody by a peptide linker. After trastuzumab deruxtecan binds to HER2 found on malignant cells, it is internalized and linker cleavage occurs through the actions of lysosomal enzymes. After it is released through cleavage, DXd causes targeted DNA damage and apoptosis in cancer cells, due to the ability to cross cell membranes.
Trastuzumab deruxtecan has been granted FDA approval for specific patients with HER-2 positive breast cancer who have failed other treatments. Trastuzumab deruxtecan was developed by Daiichi Sankyo in collaboration with AstraZeneca. In May 2022, trastuzumab deruxtecan was fully approved by the FDA.
At previous SEC meeting conducted on 26th July 2022, in response to the drug major AstraZeneca's protocol amendment version 3.0 dated 23/11/2021 for anticancer drug Trastuzumab Deruxtecan, the committee opined that the firm should present proper justification/rationale vis a vis patient safety for amendment in the protocol for further review by the committee.
