AstraZeneca gets CDSCO panel nod to study anticancer drug Durvalumab
New Delhi: Pharmaceutical major, AstraZeneca has got the go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of anti-cancer drug Durvalumab.
However, the approval is subjected to conditions that the study Principal Investigator (Medical Oncologist) and his team should have Radiotherapy expert as co-investigator or subinvestigator at each site.
Furthermore, The committee also suggested that randomization stratification should be worked out for those subjects included in the trial, who medically have resectable oesophageal squamous cell carcinoma (ESCC), however refused surgery (inclusion criteria 5).
This came after the firm presented the proposed Phase III trial protocol no. D910SC000001, Ver:2.0 dated 16Nov2021 (KUNLUN) before the committee.
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