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Organisation (CDSCO) has opined that the marketing approval of Bristol Myers Squibb anticancer drug Nivolumab should be withdrawn for the indication of hepatocellular carcinoma till safety and efficacy data are available in the Indian population.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.
It is often given when cancer has spread to other parts of the body (metastatic), cannot be surgically removed, or has come back after prior treatment. It is given as an infusion into a vein slowly, and the infusion can take 30 to 90 minutes to complete. Nivolumab is usually given once every 2 to 4 weeks. It is on the World Health Organization's List of Essential Medicines.
It was developed by Bristol Myers Squibb. Nivolumab was granted FDA approval on December 22nd, 2014.
At the recent SEC meeting for oncology and haematology held on February 24,2022, the expert panel extensively reviewed the proposal presented by the pharma major Bristol Myers Squibb regarding the voluntary withdrawal of the drug for hepatocellular carcinoma in the USA.
The committee noted that the firm was granted accelerated approval by the US FDA subject to the condition that continued approval for the indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Furthermore, the committee noted that the drug did not meet the primary endpoints in the Phase III confirmatory trial.
After detailed deliberation, the committee recommended that the firm should submit safety and efficacy data from a Phase III confirmatory clinical trial meeting the endpoint of the study for continued marketing of the drug in the indication of hepatocellular carcinoma.
Furthermore, the committee recommended that the approval for marketing for the indication in the country for hepatocellular carcinoma should be withdrawn till safety and efficacy data are available in the Indian population.
