CDSCO Panel approves Dr Reddys proposal to increase patients from 241 to 265 in India for anticancer drug Nivolumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Dr. Reddys to increase the patient numbers from 241 to 265 in India in the anticancer drug Nivolumab study.
This came after the firm presented a proposal to increase the patient numbers from 241 to 265 in India protocol no. NU-01-001. NU-01-001 is a Phase I/III clinical trial protocol for Nivolumab, an oncologic drug used to treat melanoma.
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.
Earlier, the expert panel opined the firm to 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 government sites should be included in the study.
At the recent SEC meeting for oncology held on 18th and 19th 2024, the expert panel reviewed the proposal presented by the firm to increase the patient numbers from 241 to 265 in India protocol no. NU-01-001.
After detailed deliberation, the committee recommended the approval of increasing the patient numbers from 241 to 265 in India as presented by the firm.
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