DAIICHI SANKYO, INC.

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.

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 new BLA to the FDA for datopotamab deruxtecan (dato-DXd) as a therapy for previously treated non–small cell lung cancer (NSCLC) with EGFR mutations. The BLA is based on findings from the phase 2 TROPION-Lung05 study and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials. The decision to seek accelerated approval was informed by pronounced benefits observed in EGFR-mutant 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.

54% of patients with TGCT saw tumor shrinkage with pimicotinib, compared to 3.2% in the placebo group. Pimicotinib, a once-daily CSF-1R inhibitor, showed significant improvements in stiffness and pain, and was well-tolerated. Abbisko licensed pimicotinib to Merck KGaA for $70 million upfront, aiming to develop it for various conditions.

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.