AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig
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.
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