Business Wire

Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 phase 2 trial and supported by data from additional trials including TROPION-Lung01 Previously submitted BLA based on ...
Nasdaq

AstraZeneca, Daiichi Sankyo sumbit new BLA for datopotamab deruxtecan

AstraZeneca (AZN) and Daiichi Sankyo have submitted a new Biologics License Application for accelerated approval in the US for datopotamab deruxtecan for the treatment of adult patients with locally ...
BioWorld

Daiichi Sankyo, Astrazeneca submit new BLA for Trop2 lung cancer ADC

Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth ...
Cure Today

FDA Receives Application for Dato-DXd Treatment in EGFR-Mutated NSCLC

A new BLA for Dato-DXd targets EGFR-mutated NSCLC, following withdrawal of a previous application based on TROPION-Lung01 trial data. The new submission is supported by phase 2 TROPION-Lung05 trial ...