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...
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.
Atezolizumab is a drug that is used in the management and treatment of various neoplastic conditions. It is in the monoclonal antibody class of medications.
Atezolizumab is used alone or with other drugs to treat adults with certain types of hepatocellular carcinoma (a type of liver cancer), melanoma, non-small cell lung cancer, or small cell lung cancer.
Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumors have been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1.
At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the protocol amendment version 4.0 dated 14 March 2023 protocol No. WO42633
After detailed deliberation, the committee recommended the approval of protocol amendment as presented by the firm.
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