SEC recommends approval for additional indication of AstraZeneca’s anti-cancer drug

CAR-T Digest - August 2020

03 November 2026: SEC recommends approval for additional indication of AstraZeneca’s anti-cancer drug

The Subject Expert Committee recommended approval of an additional indication for AstraZeneca’s datopotamab deruxtecan in adults with unresectable or metastatic TNBC who are not eligible for PD-1/PD-L1 inhibitor therapy. The recommendation includes a waiver of the local Phase 3 trial
The recommendation was supported by global clinical trial data, including 226 Indian patients enrolled across nine trials. The indication is already approved in the US, Russia and Brazil
The SEC recommended a Phase 4 study in India, with AstraZeneca required to submit the study protocol within three months of approval
Dato-DXd is a TROP2-directed ADC jointly developed by AstraZeneca and Daiichi Sankyo. It was previously approved in India for previously treated HR-positive, HER2-negative breast cancer