DAIICHI SANKYO, INC.

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. The drug, co-developed with AstraZeneca, aims to address significant unmet needs in advanced NSCLC treatment.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation (BTD) in the US for treating EGFRm NSCLC patients progressing after EGFR-TKI and platinum-based chemotherapy. Developed by Daiichi Sankyo and AstraZeneca, the BTD was based on TROPION-Lung05 and TROPION-Lung01 trial data. AstraZeneca and Daiichi Sankyo also submitted a Biologics License Application for accelerated approval.

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 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.

AstraZeneca and Daiichi Sankyo submitted a Biologics License Application for datopotamab deruxtecan, targeting EGFRm NSCLC patients post-systemic therapies. TROPION-Lung05 and TROPION-Lung01 trials evaluate its efficacy and safety, with TROPION-Lung01 showing promising PFS and OS results. Datopotamab deruxtecan, a TROP2-directed ADC, is part of a global clinical development program across various cancers.

Daiichi Sankyo’s “scientific trailblazer” behind blockbuster ADC medicines, Toshimori Agatsuma, has passed away.

Datopotamab deruxtecan (Dato-DXd) received FDA Breakthrough Therapy Designation for treating EGFR-mutated NSCLC post-EGFR TKI and platinum-based chemotherapy, based on TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials. It's Daiichi Sankyo's twelfth BTD in oncology, highlighting its potential to address unmet needs in NSCLC treatment.

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.