US FDA Approves Enhertu for New Early Breast Cancer Indications
Enhertu receives new US approvals for use before and after surgery in HER2-positive breast cancer, supported by positive DESTINY-Breast11 and DESTINY-Breast05 phase 3 trial results.
Daiichi Sankyo | 18/05/2026 | By News Bureau
Daiichi Sankyo Unveils 5-Year Oncology Growth Strategy
Daiichi Sankyo launches a 5-year strategy targeting global oncology leadership, aiming for 2.3 trillion yen in oncology revenue by 2030 through new indications, breakthrough technologies, and expanded commercialisation capabilities.
Daiichi Sankyo | 12/05/2026 | By News Bureau
Ifinatamab Deruxtecan Gets US Priority Review for Small Cell Lung Cancer
Ifinatamab deruxtecan receives US Priority Review for Small Cell Lung Cancer, supported by Phase 2 data, with potential as a first-in-class B7-H3 targeted Antibody Drug Conjugate.
Daiichi Sankyo | 13/04/2026 | By News Bureau | 148
Daiichi Sankyo Partners with Imagene AI for Biomarker Discovery
Through collaboration, Imagene AI and Daiichi Sankyo will apply multimodal AI to improve biomarker discovery with the goals of advancing precision oncology and enhancing clinical trial success rates.
Daiichi Sankyo | 11/04/2026 | By News Bureau | 147
PMDA Expands Use of Enhertu for Second-Line Gastric Cancer in Japan
Regulatory update allows Enhertu to be used earlier in treatment for HER2-positive advanced gastric cancer, backed by phase III data showing improved survival outcomes.
Daiichi Sankyo | 25/03/2026 | By News Bureau | 225
Leveragen Teams Up with Daiichi Sankyo for Next-Gen Biologics Innovation
Daiichi Sankyo will collaborate with Leveragen to apply its in-vivo antibody discovery platform across selected research programmes, supporting early-stage and pre-clinical development of antibody-based biologics across multiple therapeutic areas.
Daiichi Sankyo | 19/03/2026 | By News Bureau | 104
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
Daiichi Sankyo | 10/03/2026 | By News Bureau | 132
Daiichi Sankyo Submits sNDA in Japan for Datroway in First-Line Metastatic TNBC
Daiichi Sankyo files supplemental application in Japan for Datroway as a first-line treatment for metastatic triple negative breast cancer based on phase III trial data.
Daiichi Sankyo | 13/02/2026 | By News Bureau | 174
The FDA has granted Priority Review to Datroway for first-line treatment of metastatic triple-negative breast cancer patients ineligible for immunotherapy, with a regulatory decision expected in Q2 2026.
Daiichi Sankyo | 04/02/2026 | By News Bureau | 169
EU Validates ENHERTU Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer
The European Union (EU) has validated the first-line use of ENHERTU in combination with pertuzumab for patients with HER2-positive metastatic breast cancer, following results from the DESTINY-Breast09 phase-III trial, which demonstrated a significant improvement in Progression-Free Survival (PFS) compared to current standard treatments.
Daiichi Sankyo | 20/01/2026 | By News Bureau | 202
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