AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US ...

AstraZeneca, Daiichi Sankyo seek US FDA’s accelerated approval for datopotamab deruxtecan to treat advanced EGFR-mutated NSCLC ...

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial. The ...

LONDON — AstraZeneca said Tuesday it has had to resubmit a closely watched medicine for U.S. approval in a different form of ...

The original application was based on results from a phase 3 trial of Dato-DXd. Data released in September 2024 on this trial ...

Additionally, a previously submitted BLA for a broader nonsquamous NSCLC indication had been voluntarily withdrawn.

The data showed that patients with TROP2 positivity, as determined by QCS, experienced improved efficacy with Dato-DXd ...

According to the results of the TROPION-Lung01 Phase III trial, patients using Dato-DXd survived just around 13 months on ...

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial. The ...

One investigation discussed during the call involves sales reps in China allegedly changing genetic testing results to secure reimbursement for Tagrisso.

It was filed on the back of progression-free survival data from the TROPION-Lung01 study, although, there was disappointment for AZ and Daiichi Sankyo after Dato-DXd was unable to show a ...

Additionally, the partners developed a novel AI-powered biomarker to assess expression of the protein TROP2 and to conduct an exploratory analysis of their Phase III TROPION-Lung01 trial ...