Datopotamab deruxtecan

AstraZeneca and Daiichi Sankyo submitted a new BLA to the FDA seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat EGFR-mutated NSCLC, based on Phase II TROPION-Lung05 trial results. The decision follows FDA feedback and withdrawal of a previous BLA. The therapy, a TROP2-directed ADC, aims to improve outcomes for advanced lung cancer patients.

At the 2024 WCLC, 7,000+ clinicians and scientists gathered to review impactful abstracts on lung cancer treatments, including novel perioperative strategies for resectable lung cancer and the use of tyrosine kinase inhibitors, bispecific antibodies, and ADCs in advanced NSCLC and SCLC. Key findings included superior event-free survival with perioperative nivolumab, high pathologic response rates with ADCs in localized NSCLC, and promising outcomes with EGFR-MET bispecific antibodies and HER2-targeted therapies. The conference also highlighted the potential of ADCs in SCLC and the need for improved biomarker development and patient selection tools.

AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan for EGFR-mutated NSCLC, withdrawing a previous BLA for nonsquamous NSCLC. The decision was based on FDA feedback and trial data showing pronounced benefits for EGFR-mutated patients.

AstraZeneca and Daiichi Sankyo submitted a BLA to the FDA for accelerated approval of datopotamab deruxtecan (Dato-DXd) in previously treated, advanced EGFR-mutated NSCLC, based on TROPION-Lung05 Phase II trial results. The companies withdrew a previous BLA for Dato-DXd in advanced or metastatic nonsquamous NSCLC.

The FDA received a new BLA for datopotamab deruxtecan (Dato-DXd) for advanced NSCLC with EGFR mutations, supported by phase 2 TROPION-Lung05 data showing 43.6% ORR and 82.1% DCR. AstraZeneca and Daiichi Sankyo withdrew the BLA for nonsquamous NSCLC, previously accepted in February 2024. TROPION-Lung01 data showed Dato-DXd's potential benefit, especially for EGFR-mutated patients, informing the new BLA submission.

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.