CDSCO Panel Approves Roche's protocol amendment proposal for anti-cancer drug Atezoluzumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's protocol amendment proposal for the clinical trial titled " A phase III, randomised double-blind placebo-controlled clinical trial to evaluate the efficacy and safety of adjuvant Atezoluzumab or placebo and Trastuzumab Emtansibe for HER2 - Positive Breast Cancer at high risk of recurrence following preoperative therapy".
This came after the drug maker Roche presented protocol amendment version 4.0 dated 14 March 2023 protocol No. WO42633. This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.
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