AstraZeneca and Daiichi Sankyo Report the US FDA’s BLA Acceptance of Datopotamab Deruxtecan with Priority Review for EGFR-mutated NSCLC
Shots:
- FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA
- BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings from P-II & P-III depicted confirmed ORR of 47% & mDoR of 7mos., with consistent safety
- Dato-DXd is also being assessed in 7 P-III studies, incl. TROPION-Lung14 & TROPION-Lung15 with/without Tagrisso to treat advanced or metastatic EGFRm non-squamous NSCLC
Ref: AstraZeneca | Image: AstraZeneca & Daiichi Sankyo
Related News:- AstraZeneca’s Tagrisso (Osimertinib) Secures the EC’s Approval to Treat Unresectable EGFR-Mutated Lung Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
