Datopotamab deruxtecan

AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan (Dato-DXd) for EGFR-mutated NSCLC, withdrawing a previous BLA for nonsquamous NSCLC based on FDA feedback. The new BLA is supported by TROPION-Lung05 Phase II trial data and will be presented at ESMO Asia 2024.

Datopotamab deruxtecan, an investigational TROP2-directed ADC, is being evaluated in multiple clinical trials for advanced NSCLC, including TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01. These trials assess efficacy and safety in patients with actionable genomic alterations and those requiring systemic therapy following prior treatment. Primary endpoints include objective response rate (ORR) and progression-free survival (PFS). AstraZeneca and Daiichi Sankyo collaborate on the development and commercialization of datopotamab deruxtecan.

AstraZeneca and Daiichi Sankyo withdrew an approval application for lung cancer drug dato-dxd, replacing it with a new one targeting EGFR-mutated tumors, aiming for an 'accelerated' approval in previously treated patients. This decision, based on pooled analysis showing pronounced benefit in EGFR-mutated patients, could limit the drug's sales potential.

AstraZeneca resubmits Dato-DXd for U.S. approval in a different form of lung cancer, delaying market entry and raising questions about its potential use. The drug, a next-generation chemotherapy, did not outperform standard chemotherapy in overall survival trials.

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AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous BLA for nonsquamous NSCLC. The decision followed FDA feedback. Results from TROPION-Lung05 and TROPION-Lung01 trials will be presented at ESMO Asia 2024.

AstraZeneca and Daiichi Sankyo withdrew the BLA for datopotamab deruxtecan in nonsquamous NSCLC, opting to submit a new BLA for EGFR-mutated NSCLC based on FDA feedback and trial results. The decision was informed by TROPION-Lung01 and TROPION-Lung05 trials, with new data to be presented at ESMO Asia 2024. Datopotamab deruxtecan, a TROP2-directed ADC, is under evaluation in ongoing Phase III trials for NSCLC treatment, including combinations with Tagrisso, aiming to validate biomarkers and improve patient outcomes.

Daiichi Sankyo and AstraZeneca submitted a new BLA for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous BLA for nonsquamous NSCLC. The decision followed FDA feedback, aiming to offer new hope for patients with challenging EGFR-mutated NSCLC.

Daiichi Sankyo and AstraZeneca submitted a new Biologics License Application for datopotamab deruxtecan targeting EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. They withdrew a previous application for nonsquamous NSCLC. The decision followed FDA feedback, aiming to offer new hope for patients with challenging EGFR-mutated NSCLC.

Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated U.S. approval of datopotamab deruxtecan for EGFR-mutated NSCLC, based on TROPION-Lung05 trial data. Previously submitted BLA for nonsquamous NSCLC was withdrawn. The decision followed FDA feedback, aiming to offer new hope for patients with advanced EGFR-mutated NSCLC.