AstraZeneca anticancer drug Trastuzumab Deruxtecan protocol amendment proposal approved by CDSCO panel
Based on the justification provided by the pharma major AstraZeneca, the Subject Expert Committee(SEC) functional under Central Drug Standard Control Organization(CDSCO) has approved the protocol amendment proposal for anticancer drug Trastuzumab Deruxtecan (T-DXd), which is an antibody used to treat certain types of unresectable or metastatic HER-2 positive breast cancer.
This came after the firm presented justification/rationale vis-a-vis patient safety for the proposed protocol Amendment version 3.0 dated 23-Nov-2021 to the protocol no. D967C00001 before the committee.
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