Datopotamab deruxtecan

The FDA granted breakthrough therapy designation to Daiichi Sankyo's ADC datopotamab deruxtecan for EGFR-mutated NSCLC, based on early TROPION-Lung05 trial results showing clinically meaningful tumor response in previously treated patients.

The FDA granted breakthrough therapy designation to datopotamab deruxtecan for EGFR-mutated NSCLC progressing after EGFR TKI and platinum-based chemotherapy. Data from TROPION-Lung05 and TROPION-Lung01 trials showed an ORR of 42.7%, DCR of 86.3%, and median OS of 15.6 months. AstraZeneca and Daiichi Sankyo submitted a BLA for accelerated approval in November 2024.

Datopotamab deruxtecan granted Breakthrough Therapy Designation by FDA for EGFR-mutated NSCLC, based on TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials. This marks the first BTD for datopotamab deruxtecan and the twelfth for Daiichi Sankyo's oncology pipeline.

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.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFRm NSCLC patients progressing after EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 and TROPION-Lung01 trial data.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

Datopotamab deruxtecan granted Breakthrough Therapy Designation in US for treating advanced EGFR-mutated NSCLC after EGFR-TKI and platinum-based chemotherapy. Based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trial data, presented at ESMO Asia 2024.

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.