AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study to evaluate Dato-DXd and Durvalumab for neoadjuvant/adjuvant treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer.
This came after drug major AstraZeneca presented Phase III clinical trial protocol No. D926QC00001.
The above study is phase III randomised study to evaluate Dato-DXd and Durvalumab for neoadjuvant/adjuvant treatment of triple-negative or hormone receptor-low/HER2-negative Breast Cancer. This is a Phase III, 2-arm, randomised, open-label, a multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC (Triple negative breast cancer) or hormone receptor-low/HER2-negative breast cancer.
Datopotamab Deruxtecan (Dato-DXd), a Novel TROP2-directed Antibody–drug Conjugate, demonstrates potent antitumor activity by efficient drug delivery to tumor cells. The pharmacologic activity and mechanism of action of Dato-DXd were investigated in several human cancer cell lines and xenograft mouse models including patient-derived xenograft (PDX) models.
