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.
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