Datopotamab deruxtecan

Datopotamab deruxtecan (Dato-DXd), developed by Daiichi Sankyo and AstraZeneca, received FDA Breakthrough Therapy Designation for treating EGFR-mutated NSCLC. Supported by TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials, it aims to address unmet needs in patients with disease progression post-EGFR TKI and platinum-based chemotherapy.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFR-mutated NSCLC patients post EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trials. This marks the first BTD for Dato-DXd, highlighting its potential in addressing significant unmet needs in NSCLC treatment.

Datopotamab deruxtecan (Dato-DXd) received FDA Breakthrough Therapy Designation for treating advanced EGFR-mutated NSCLC post-EGFR TKI and platinum-based chemotherapy, based on TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trial data. This marks the first BTD for Dato-DXd and the twelfth across Daiichi Sankyo’s oncology pipeline, highlighting its potential to address unmet needs in NSCLC treatment.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation (BTD) in the US for treating EGFR-mutated non-small cell lung cancer (NSCLC) patients who progressed after EGFR-TKI and platinum-based chemotherapy. The BTD was based on Phase II and III trial data, marking the first BTD for datopotamab deruxtecan.

The FDA granted breakthrough therapy designation to Daiichi Sankyo's datopotamab deruxtecan for treating EGFR-mutated NSCLC, based on promising Phase II trial results. This ADC, developed with AstraZeneca, aims to address unmet needs in advanced NSCLC treatment, with ongoing trials evaluating its efficacy and safety.

AstraZeneca and Daiichi Sankyo's cancer drug dato-dxd showed tumor control for 6 months in EGFR-mutated lung cancer patients; Agenus plans 60% spending cut to focus on late-stage colorectal cancer immunotherapy; Amgen invests $1 billion to expand NC manufacturing; USPTO withdraws proposed rule on preventing 'patent thickets'; Bluebird bio to undergo reverse stock split; FDA grants accelerated approval to Merus' zenocutuzumab for NRG1-altered lung and pancreatic cancers.

AstraZeneca's Imfinzi approved in the US for limited-stage small cell lung cancer (LS-SCLC) after chemotherapy and radiation, based on ADRIATIC trial results showing improved survival and reduced risk of death and disease progression.

FDA grants Priority Review to AstraZeneca's Imfinzi for muscle-invasive bladder cancer, based on NIAGARA Phase 3 trial data showing a 32% reduction in disease progression risk. Estimated 67.8% event-free survival at two years with Imfinzi versus 59.8% in the comparator arm. Imfinzi also reduced death risk by 25% in overall survival analysis.