Datopotamab deruxtecan

The FDA granted breakthrough therapy designation to Daiichi Sankyo's antibody-drug conjugate datopotamab deruxtecan for treating EGFR-mutated non-small cell lung cancer, based on early results from the TROPION-Lung05 Phase II trial.

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.

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.

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.