Weekly Digest - December 2024
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - December 2024
09 Dec 2024: Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
Datopotamab deruxtecan (Dato-DXd) has received Breakthrough Therapy Designation (BTD) from the US FDA for treating advanced EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have progressed after EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy
- The designation is based on data from the TROPION-Lung05 Phase II trial and supporting evidence from the TROPION-Lung01 Phase III trial, with results presented at the ESMO Asia 2024 Congress
- Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo, designed to target a protein expressed in most NSCLC tumors
- AstraZeneca and Daiichi Sankyo have also submitted a Biologics License Application for accelerated approval of datopotamab deruxtecan in the US for previously treated EGFR-mutated NSCLC patients
