Conduct BE study or present safety data: CDSCO Panel tells IQVIA on anti-cancer Drug Daratumumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined IQVIA to conduct the bioequivalence study or present safety data for the anti-cancer monoclonal antibody medication, Daratumumab.
This came after IQVIA presented phase 1/3 clinical study protocol no.: CT-P44 3.1 version no. 1.0 dated 21-OCT-2024.
Daratumumab is a monoclonal antibody that treats multiple myeloma (MM) by binding to the CD38 protein on MM cells. This binding triggers a series of events that lead to the death of MM cells. Daratumumab binds to CD38, causing cells to apoptose via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer or antibody-dependent cellular phagocytosis.
Daratumumab binds to CD38, a protein that's overexpressed on MM cells. This binding activates the immune system to recognize the MM cells. The immune system then attacks and kills the MM cells.
At the recent SEC meeting for Oncology held on February 20, 2025, the expert panel reviewed the phase 1/3 clinical study protocol no.: CT-P44 3.1 version no. 1.0 dated 21-OCT-2024.
After detailed deliberation, the committee opined that the firm should conduct a bioequivalence study or present safety data for further review by the committee.
