CDSCO Panel grants Bristol Myer Squibb's Proposal for Additional Indication of anti-cancer drug Nivolumab
New Delhi: Noting that sufficient safety data is established, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Bristol-Myers Squibb for approval of additional indication for the drug product Nivolumab 10mg/mL concentrate for solution for infusion.
This came after the drug maker Bristol-Myers Squibb presented their proposal for approval of additional indication for the drug product Nivolumab 10mg/mL concentrate for a solution for infusion based on the clinical data generated from a global clinical trial with a request for a local clinical trial waiver.
The committee noted that the drug was already approved and sufficient safety data was established.
Nivolumab is an oncologic drug that belongs to the immune checkpoint inhibitor (ICI) class. Nivolumab is a prescription medicine used to treat adults and children 12 years of age and older with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
Nivolumab binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby relieving T-cell exhaustion and improving cytokine production. This process may also target normal cells.
At the recent SEC meeting for Oncology held on 9th and 10th January 2023, the expert panel reviewed the proposal presented by Bristol-Myers Squibb for approval of additional indication for the drug product Nivolumab 10mg/mL concentrate for solution for infusion.
After detailed deliberation, the committee recommended approval of the proposed additional indication with a local clinical trial waiver.
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