DAIICHI SANKYO, INC.

The FDA granted Breakthrough Therapy Designation to AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) for EGFR-mutated NSCLC patients who progressed after EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 and TROPION-Lung01 trials. Lung cancer is the leading cause of cancer deaths in the US, with NSCLC accounting for 80-85% of cases.

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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 (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.

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