All SAEs including death should be reported: CDSCO Panel tells AstraZeneca about Durvalumab
New Delhi: Granting the protocol amendment proposal presented by drug major AstraZeneca for anticancer drug Durvalumab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has stated that all serious adverse events (SAEs) including death irrespective of its cause should be reported to CDSCO as per provision of New Drugs and Clinical Trials Rules (NDCT Rules) 2019 by the principal investigator (PI) and Sponsor.
This came after the applicant presented protocol amendment version 2.0 (amendment 1) dated 02-08-2022 before the committee.
Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
Durvalumab blocks the interaction of PD-L1 with PD-1 and CD80 (B7. 1) to release the inhibition of immune responses, without inducing antibody-dependent cell-mediated cytotoxicity
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