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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.
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751