CDSCO panel Approves AstraZeneca's Protocol Amendment proposal for Datopotamab Deruxtecan study

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-07T18:15:58+05:30 | Updated On 7 Nov 2024 6:15 PM IST

CDSCO panel approves protocol amendment of DATODXT study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's protocol amendment proposal to study anticancer drug Datopotamab Deruxtecan (DATODXT, DS-106)

This came after the firm presented protocol amendment 3.0 version 4.0 dated 30 July 2024, protocol no. D926PC00001. This is a study of Dato-DXd Versus the Investigator's choice chemotherapy in Patients with Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

Dato-DXd is a combination of a humanized anti-TROP2 antibody and a topoisomerase I inhibitor payload. The antibody binds to TROP2, a protein that's overexpressed in tumors and associated with increased aggressiveness and metastasis. The payload is then released, which targets DNA topoisomerase I and inhibits DNA replication, resulting in tumor cell death.

Dato-DXd is being studied in clinical trials for multiple cancers, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and HR-positive, HER2-negative breast cancer.

At the recent SEC meeting for Oncology held on 23rd October 2024, the expert panel reviewed the protocol amendment 3.0 version 4.0 dated 30 July 2024 protocol no. D926PC00001.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: CDSCO panel approves Sanofi Healthcare's protocol amendment proposal to study SAR441566

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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.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751