A new BLA for datopotamab deruxtecan aims for FDA accelerated approval to treat EGFR-mutated NSCLC based on data from ...

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The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial.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

The companies have voluntarily withdrawn the BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 Phase III trial.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

Additionally, a previously submitted BLA for a broader nonsquamous NSCLC indication had been voluntarily withdrawn.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries across the globe. It is approved as a single-use pre-filled syringe and auto-injector ...

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 ...

Three phase 3 trials of combinations including datopotamab deruxtecan for the treatment of non–small cell lung cancer are beginning.

in the TROPION-Lung01 study. There was also an “early trend” towards an improvement in overall survival with the ADC, although that data isn’t yet mature, said the drugmakers in a joint ...

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t ...

AstraZeneca shared detailed results from the TROPION-Lung01 Phase 3 trial of datopotamab deruxtecan for non-small cell lung cancer, showing a clinically meaningful trend in overall survival ...