AstraZeneca Gets CDSCO Panel nod to study Anti-cancer Drug Datopotamab Deruxtecan 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 clinical trial of the anti-cancer drug Datopotamab deruxtecan (Dato-DXd, DS-1062a) 100mg/vial and Durvalumab (MEDI4736) 500mg/vial (50mg/mL).
This came after the drug major AstraZeneca presented Phase III clinical study protocol No. D7630C00001 version 2.0 dated 11 September 2023.
The above-mentioned study is a phase III, open-label, randomized study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab Compared with investigator’s choice of chemotherapy (Paclitaxel, Nab-paclitaxel, or Gemcitabine + Carboplatin) in combination with Pembrolizumab in patients with PD-L1 positive locally recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
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