CDSCO Panel approves Phase IV CT of Hetero-Trastuzumab marketed formulation
New Delhi: Drug major Hetero Biopharma has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for conducting the post-marketing study to evaluate the safety, immunogenicity, and efficacy of the marketed formulation of Hetero-Trastuzumab in female patients with human epidermal growth factor receptor 2-positive...
New Delhi: Drug major Hetero Biopharma has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for conducting the post-marketing study to evaluate the safety, immunogenicity, and efficacy of the marketed formulation of Hetero-Trastuzumab in female patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
This came after the firm presented the proposal for the conduct of a Phase IV clinical trial titled "A Phase IV multi-centric, post-marketing study evaluating the safety, immunogenicity, and efficacy of the marketed formulation of Hetero-Trastuzumab in female patients with HER2+ breast cancer," vide protocol HCR/IV/TRUMAB/05/2022 version 1.0 dated 14 May 2022.
Trastuzumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells. Trastuzumab binds to an extracellular domain of this receptor and inhibits HER2 homodimerization, thereby preventing HER2-mediated signaling. It is also thought to facilitate antibody-dependent cellular cytotoxicity, leading to the death of cells that express HER2.
Trastuzumab is a biological agent primarily used in the treatment of HER2-positive breast cancer. It may be used as adjuvant therapy for a localized disease or as first-line therapy for metastatic disease.
At the recent SEC meeting for oncology and hematology held on February 23, 2023, the expert panel reviewed the proposal for conducting the Phase IV clinical trial, "A Phase IV multi-centric, post-marketing study evaluating the safety, immunogenicity, and efficacy of the marketed formulation of Hetero-Trastuzumab in female patients with HER2+ breast cancer," vide protocol HCR/IV/TRUMAB/05/2022 version 1.0 dated 14 May 2022.
Following extensive deliberation, the committee recommended that the Phase IV study of Trastuzumab 150 mg and 440mg in a vial, as presented by the firm, be approved.
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