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News about "Ken Takeshita"
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.
Ken Takeshita | 04/02/2026 | By News Bureau
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.
Ken Takeshita | 20/01/2026 | By News Bureau | 128
Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
Ken Takeshita | 23/12/2025 | By News Bureau
Daiichi Sankyo has dosed the first patient in a phase 1 clinical trial of DS3610, its investigational STING agonist Antibody Drug Conjugate (ADC), marking a key step in advancing novel immunotherapy approaches for patients with advanced solid tumours.
Ken Takeshita | 12/11/2025 | By Dineshwori | 452
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Ken Takeshita | 25/09/2025 | By Dineshwori | 111
FDA Grants BTD to Raludotatug Deruxtecan for Platinum-Resistant Ovarian Cancer
This is the first BTD granted for Raludotatug Deruxtecan, the second for the Daiichi Sankyo-Merck partnership and the 15th across Daiichi Sankyo’s oncology portfolio, marking a significant milestone in the companies’ joint efforts to develop innovative cancer therapies.
Ken Takeshita | 16/09/2025 | By Dineshwori | 169
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