CDSCO approves AstraZeneca Anticancer Drug Trastuzumab Deruxtecan Protocol Amendment

Written by Dr. Divya Colin Published On 2022-08-21T14:00:41+05:30 | Updated On 21 Aug 2022 2:00 PM IST

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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..

This came after the firm presented justification/rationale vis-a-vis patient safety for the proposed protocol Amendment version 3.0 dated 23-Nov-2021 to the protocol no. D967C00001 before the committee.

Earlier the Medical Dialogues Team had reported that AstraZeneca had got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase 3 clinical trial of oncology drug Trastuzumab Deruxtecan. Further, regarding the clinical trial, the committee had noted that the safety profile of the study drug from preclinical and clinical studies justified the conduct of the trial.

Also Read:AstraZeneca Gets CDSCO Panel Nod To Conduct Cancer Drug Trastuzumab Deruxtecan Study

Trastuzumab deruxtecan is a HER-2 directed antibody attached to a topoisomerase inhibitor that is approved for use in certain types of metastatic, unresectable breast cancer. It is classified as an antibody-drug conjugate. The cleavable peptide linker used to bind the antibody and drug in this product distinguishes it from other members of its class.

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.

At the recent SEC meeting for Oncology and Hematology held on 05.08.2022,the expert panel extensively reviewed the justification/rationale vis-a-vis patient safety of the anticancer drug TrastuzumabDeruxtec an (T-DXd) presented by the firm.

After detailed deliberation, the committee recommended the approval of the proposed protocol amendment.

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.