Conduct Phase III CT: CDSCO Panel Tells Biocon Biologics Over Anti-cancer Drug Nimutuzumab
New Delhi: Observing that there is no convincing data available for the proposed additional indication for the drug Nimutuzumab, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the drug major Biocon Biologics to conduct the Phase III clinical trial of the anti-cancer drug Nimutuzumab for the patients suffering from Advanced Esophageal Squamous Cell Carcinoma (ESCC).
This came after the firm presented the proposal for a grant of permission for an additional indication for the treatment of patients suffering from Advanced Esophageal Squamous Cell Carcinoma (ESCC) with the waiver of a local clinical trial.
Nimotuzumab is an EGFR-targeting monoclonal antibody used in the treatment of squamous cell carcinomas of the head and neck and glioblastomas.
Nimutuzumab works by targeting the epidermal growth factor receptor with superior potency, thereby inhibiting receptor activation and ligand binding. This drug is used in the treatment of squamous cell carcinomas of the head and neck.
At the recent SEC meeting for Oncology and Hematology held on 22nd June 2023, the expert panel reviewed the proposal presented by Biocon Biologics for the grant of permission for an additional indication of Nimutuzumab Injection 50 mg/10 mL for the treatment of patients suffering from Advanced Esophageal Squamous Cell Carcinoma (ESCC) with a waiver of a local clinical trial.
The committee observed that there is no convincing data available for the proposed additional indication.
After detailed deliberation, the committee recommended that the firm should conduct a Phase III clinical trial in India in the proposed indication.
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