Submit preclinical data in animal and Phase I CT data: CDSCO Panel Tells IQVIA on Pembrolizumab study

New Delhi: After reviewing the Phase I/III clinical study protocol of the anti-cancer drug Pembrolizumab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined IQVIA RDS (India) to submit preclinical study data in animals, Phase-I complete study data including all pharmacokinetic and immunogenicity data.

This came after IQVIA RDS (India) presented phase I/III clinical study protocol no:BAT-3306-002-CR, Version:1.0, dated 19 Dec 2023.

Pembrolizumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells

Pembrolizumab binds to the PD-1 receptor on T cells, preventing the PD-1 receptor from binding to its ligands, PD-L1 and PD-L2. This allows T cells to function normally and attack cancer cells.

At the recent SEC meeting for Oncology held on 9th October 2024, the expert panel reviewed the phase I/III clinical study protocol no:BAT-3306-002-CR, Version:1.0, dated 19 Dec 2023.

After detailed deliberation, the committee opined that the firm should submit preclinical study data in animals, and Phase-I complete study data including all pharmacokinetic and immunogenicity data for further review by the committee.

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