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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