Bristol Myers Squibb Nivolumab marketing approval to be revoked for hepatocellular carcinoma: CDSCO panel
New Delhi: In a major setback for Bristol Myers Squibb, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has opined that the marketing approval of Bristol Myers Squibb anticancer drug Nivolumab should be withdrawn for the indication of hepatocellular carcinoma till safety and efficacy data are available in the Indian population.
This came after the firm presented their proposal for voluntary withdrawal of the drug in hepatocellular carcinoma in the USA.
In addition, the drug-maker also informed the expert panel that a confirmatory Phase III clinical trial related to the use of Nivolumab as monotherpay in the hepatocellular indication is ongoing overseas.
Nivolumab is a human IgG4 monoclonal antibody that is a PD-1 blocking antibody used to treat melanoma, non small-cell lung cancer, renal cell cancer, head and neck cancer, and Hodgkin lymphoma.
The ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T-cells, inhibiting the action of these cells. Tumor cells express PD-L1 and PD-L2. Nivolumab binds to PD-1, preventing PD-L1 and PD-L2 from inhibiting the action of T-cells, restoring a patient's tumor-specific T-cell response.
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