AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-17T18:00:50+05:30 | Updated On 21 March 2024 8:54 PM IST

CDSCO panel approves protocol amendment of DATODXT study

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the study of the anticancer drug Volrustomig (MEDI5752).

This came after the drug maker AstraZeneca presented phase III clinical study protocol No. D798EC00001.

This is a global study of Volrustomig (MEDI5752) for participants with unresected locally advanced head and neck squamous cell carcinoma following definitive concurrent chemoradiotherapy (eVOLVE-HNSCC).

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

MEDI5752 is a monovalent bispecific antibody designed to suppress the PD-1 pathway and provide modulated CTLA4 inhibition favoring enhanced blockade on PD-1+ activated T cells.

At the recent SEC meeting for Oncology held on 21st February 2023, the expert panel reviewed the Phase III CT protocol No. D798EC00001.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

Also Read:Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan

astrazenecacdscoanticancer drughead and neck squamous cell cancerchemotherapy

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