Determine efficacy of immunotherapy in PD-L1 negative and low patients: CDSCO Panel Tells Dr Reddy on Nivolumab
New Delhi: Based on the Phase I/III clinical trial protocol of the anti-cancer drug Nivolumab presented by the drug major Dr Reddy Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to recalculate the sample size, determine the efficacy of immunotherapy in PD-L1 negative and low (< 1% and up to...
New Delhi: Based on the Phase I/III clinical trial protocol of the anti-cancer drug Nivolumab presented by the drug major Dr Reddy Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to recalculate the sample size, determine the efficacy of immunotherapy in PD-L1 negative and low (< 1% and up to 10%) patients and other.
This came after the drug major Dr. Reddy Laboratories presented Phase I/III clinical trial protocol No. NU-01-001.
Nivolumab is an oncologic drug that belongs to the immune checkpoint inhibitor (ICI) class. 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.
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.
At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the Phase I/III clinical trial protocol No. NU-01-001.
After detailed deliberation, the committee opined that the firm should present the following for further review by the committee:
1. Recalculation of sample size considering 95% CI.
2. Efficacy of immunotherapy in PD-L1 negative and low (< 1% and up to 10%) patients.
3. Inclusion/exclusion criteria, Efficacy, and safety endpoints should be the same as the innovator’s study design.
4. Detailed Kinetics study data should be submitted.
5. More geographically distributed Govt. sites should be included in the study.
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