Pfizer Gets CDSCO Panel Nod To Study Anticancer Drug Disitamab vedotin
Pfizer
New Delhi: Citing that more geographically distributed government sites shall be included in the study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the drug major Pfizer for conducting phase 3 clinical study of the anti-cancer drug Disitamab vedotin.
The expert panel further suggested that the principal investigator (PI) shall be a medical oncologist only.
This came after the drug maker Pfizer presented phase 3 clinical study protocol no. C5731001 amendment 03 dated 03-December-2024.
Disitamab vedotin is an antibody-drug conjugate drug targeting human epidermal growth factor receptor 2 (HER2). It is currently being investigated for cancer.
Disitamab vedotin, an antibody-drug conjugate (ADC), targets HER2-expressing cancer cells. It works by binding to HER2, being internalized, and releasing the cytotoxic payload MMAE, which inhibits tubulin polymerization, leading to cell death and potentially bystander killing.
At the recent SEC meeting for Oncology held on 11th March 2025, the expert panel reviewed the phase 3 clinical study protocol no. C5731001 amendment 03 dated 03-December-2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the following condition:
1. More geographically distributed government sites shall be included in the study.
2. PI shall be a medical oncologist only.
