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15.12.2025
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ENHERTU® Plus Pertuzumab Approved in the U.S. as First New Treatment in More Than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer
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ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer, as determined by a U.S Food and Drug Administration (FDA)-approved test.
E...
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09.12.2025
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DESTINY-Ovarian01 Phase 3 Trial of ENHERTU® Initiated as First-Line Maintenance Therapy in Patients with HER2 Expressing Advanced Ovarian Cancer
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The first patient has been dosed in the randomization phase of the DESTINY-Ovarian01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer following trea...
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08.12.2025
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Daiichi Sankyo Showcases Strength of Industry-Leading ADC Portfolio with Latest Research Updates from Five Landmark Breast Cancer Trials at SABCS
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Daiichi Sankyo (TSE: 4568) will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU® (trastuzumab deruxt...
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20.10.2025
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03.12.2025
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Federal Circuit Court of Appeals Vacates Infringement Judgment and Damages Award in Dispute between Daiichi Sankyo and Seagen
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On December 2, the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit) reversed a decision from the U.S. District Court for the Eastern District of Texas that found Seagen Inc’s U.S. Patent No. 10,808,039 (the ’039 patent) not invalid (the Texas decision). In view of the reversal, the Federal Circuit vacated the Texas court’s relat...
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20.10.2025
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12.11.2025
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General Proximity Announces Multi-Target Collaboration with Daiichi Sankyo to Discover and Advance Novel Oncology Therapeutics Using OmniTAC™ Platform
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- The collaboration will leverage General Proximity's OmniTAC™ platform to identify and advance next generation induced proximity agents for high value oncology targets.
- Induced proximity medicines, powered by the OmniTAC™ platform, enable precise modulation o...
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10.11.2025
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DS3610 Enters Clinical Development in Patients with Advanced Solid Tumors as First STING Agonist ADC in Industry-Leading ADC Portfolio of Daiichi Sankyo
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The first patient has been dosed in a first-in-human phase 1 trial evaluating DS3610 in patients with advanced, metastatic or unresectable solid tumors.
DS3610 is an investigational STING agonist antibody drug conjugate (ADC) containing an immunomodulatory payload discovered by Daiichi Sankyo (TSE:4568).
Despite the availability of various can...
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31.10.2025
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DESTINY-Lung06 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients with HER2 Overexpressing Metastatic Non-Squamous Non-Small Cell Lung Cancer
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The first patient has been dosed in the DESTINY-Lung06 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) plus pembrolizumab versus pembrolizumab, platinum-based chemotherapy and pemetrexed as a first-line treatment in patients with unresectable, locally advanced or metastatic HER2 overexpressing and PD-L1 TPS <50% non-squamous non-smal...
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19.10.2025
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DS-3939 Shows Promising Preliminary Clinical Activity in Patients with Advanced Solid Tumors in Phase 1/2 Trial
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Initial results from the dose escalation part of the first-in-human phase 1/2 trial of DS-3939 demonstrated promising clinical activity in patients with previously treated advanced solid tumors refractory to standard treatment. These data were presented today during a proffered paper session (917O) at the 2025 European Society for Medical Oncology...
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19.10.2025
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DATROWAY® Demonstrated an Unprecedented Median Overall Survival Improvement of Five Months Vs Chemotherapy as First-line Treatment for Patients with Metastatic Triple Negative Breast Cancer for Whom Immunotherapy Was Not an Option in TROPION-Breast02
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Positive results from the TROPION-Breast02 phase 3 trial showed DATROWAY® (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as first-line treatment for p...
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18.10.2025
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ENHERTU® Reduced the Risk of Disease Recurrence or Death by 53% Versus T-DM1 in Patients with High-Risk HER2 Positive Early Breast Cancer Following Neoadjuvant Therapy in DESTINY-Breast05 Phase 3 Trial
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Positive results from the DESTINY-Breast05 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment (after surgery) in patients with HER2 positive ear...
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18.10.2025
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ENHERTU® Followed by THP Before Surgery Resulted in a Pathologic Complete Response in 67% of Patients with High-Risk HER2 Positive Early-Stage Breast Cancer in DESTINY-Breast11 Phase 3 Trial
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Positive results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate when compared with dose-...
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17.10.2025
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DATROWAY® Plus Rilvegostomig Showed Promising Tumor Responses in Patients with Metastatic Urothelial Cancer in TROPION-PanTumor03 Phase 2 Trial
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Initial results from one sub-study of the TROPION-PanTumor03 phase 2 trial showed that DATROWAY® (datopotamab deruxtecan) plus rilvegostomig showed promising tumor responses and disease control as first-line and second-line combination therapy in patients with locally advanced or metastatic urothelial cancer. These results were presented today as...
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20.10.2025
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06.10.2025
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DATROWAY® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Overall Survival as First-Line Therapy for Patients with Metastatic Triple Negative Breast Cancer for Whom Immunotherapy Was Not an Option in TROPION-Breast02
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Positive topline results from the TROPION-Breast02 phase 3 trial showed DATROWAY® (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatme...
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02.10.2025
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Daiichi Sankyo Establishes Third Research Institute in San Diego
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Daiichi Sankyo (TSE: 4568) has established Daiichi Sankyo Research Institute in San Diego, representing the third research institute established outside of the company’s flagship research center in Japan since the opening of locations in Boston and Munich in 2024.
“Establishing a dedicated scientific presence in San Diego marks a significant mil...
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01.10.2025
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ENHERTU® Followed by THP Supplemental Biologics License Application Accepted in the U.S. for Patients with High-Risk HER2 Positive Early-Stage Breast Cancer Prior to Surgery
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) sta...
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24.09.2025
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ENHERTU® Plus Pertuzumab Granted Priority Review in the U.S. as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted Priority Review in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive bre...
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11.09.2025
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ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors
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The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treat...
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14.08.2025
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Daiichi Sankyo Presents New Data in Small Cell Lung Cancer and Updates Across ADC Portfolio Highlighting Progress in Creating New Standards of Care for Patients with Lung Cancer at WCLC
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Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in lung cancer at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25).
Data at WCLC will showcase the company’s progress towards creating new standards of c...
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17.07.2025
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ENHERTU® Plus Pertuzumab Granted Breakthrough Therapy Designation in the U.S. as First-Line Therapy for Patients with HER2 Positive Metastatic Breast Cancer
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ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered b...
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09.07.2025
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TURALIO® Final Long-Term Data Showed Sustained Clinical Benefit in Patients with Tenosynovial Giant Cell Tumor from Open-Label Extension of ENLIVEN Phase 3 Trial
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Final long-term efficacy and safety results from the open-label extension of the ENLIVEN phase 3 trial showed a sustained clinical benefit from long-term treatment with TURALIO® (pexidartinib) in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. These results, consistent with the primary analy...
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23.06.2025
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DATROWAY® Approved in the U.S. as First TROP2 Directed Therapy for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
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DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective respon...
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16.06.2025
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VANFLYTA® is Now Approved in Canada Specifically for Adult Patients with Newly Diagnosed FLT3-ITD Positive AML
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After ENHERTU®, VANFLYTA® is the second innovative medicine from the Daiichi Sankyo oncology pipeline to be available in CanadaApproval based on QuANTUM-First results demonstrating VANFLYTA added to chemotherapy improved overall survival...
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09.06.2025
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DESTINY-Endometrial01 Phase 3 Trial of ENHERTU® Initiated as First-Line Therapy in Patients with HER2 Expressing Primary Advanced or Recurrent Endometrial Cancer
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The first patient has been dosed in the DESTINY-Endometrial01 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch...
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02.06.2025
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ENHERTU® Plus Pertuzumab Reduced the Risk of Disease Progression or Death by 44% Versus THP as First-Line Therapy in Patients with HER2 Positive Metastatic Breast Cancer in DESTINY-Breast09 Phase 3 Trial
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Positive results from the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive meta...
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01.06.2025
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DATROWAY® Continues to Show Promising Tumor Responses as Part of Combination Regimens in Patients with Early and Advanced Non-Small Cell Lung Cancer
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Results from three trials continue to demonstrate the potential of DATROWAY® (datopotamab deruxtecan) in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease. These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025...
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31.05.2025
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ENHERTU® Reduced the Risk of Death by 30% Versus Ramucirumab Plus Paclitaxel as a Second-Line Therapy in Patients with HER2 Positive Unresectable or Metastatic Gastric Cancer in DESTINY-Gastric04 Phase 3 Trial
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Positive results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab plus paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric...
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22.05.2025
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Daiichi Sankyo Continues to Transform Treatment Landscape for Patients with Cancer with Practice-Changing Data at ASCO
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Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology Scientific Program (#ASCO25).
Data at ASCO showcasing the company’s progress towards creating new standards of care for patients with cancer will include two...
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07.05.2025
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ENHERTU® Followed by THP Before Surgery Showed Statistically Significant and Clinically Meaningful Improvement in Pathologic Complete Response in Patients With High-Risk HER2 Positive Early-Stage Breast Cancer in DESTINY-Breast11 Phase 3 Trial
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Positive topline results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophospha...
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21.04.2025
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ENHERTU® Plus Pertuzumab Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival Versus THP as First-Line Therapy for Patients with HER2 Positive Metastatic Breast Cancer
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Positive topline results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a fir...
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08.04.2025
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DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
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DATROWAY® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.
DATROWAY i...
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04.04.2025
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ENHERTU® Approved in the EU as First HER2 Directed Therapy for Patients with HR Positive, HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breas...
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31.03.2025
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DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Positive Advanced Gastric Cancer
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The first patient has been dosed in the DESTINY-Gastric05 phase 3 trial evaluating ENHERTU® (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) versus trastuzumab in combination with platinum-based che...
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03.03.2025
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ENHERTU® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Overall Survival in Patients with HER2 Positive Metastatic Gastric Cancer at Interim Analysis of DESTINY-Gastric04 Phase 3 Trial
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Positive topline results from the DESTINY-Gastric04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+) unresect...
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28.02.2025
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ENHERTU® Recommended for Approval in the EU by CHMP for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane...
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04.02.2025
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Survey Reveals: 88% of Western Europeans Would Like Better Information on Breast Cancer, Misconceptions and Lack of Awareness of the Disease Still Prevail
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A new survey sponsored by Daiichi Sankyo and AstraZeneca reveals that there is a need for more readily available information on breast cancer, with results revealing misconceptions and a lack of public awareness. The survey conducted across the major five European countries with 7,750 respondents found varying levels of public knowledge about brea...
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31.01.2025
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Datopotamab Deruxtecan Recommended for Approval in the EU by CHMP for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
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Datopotamab deruxtecan (Dato-DXd) has been recommended for approval in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setti...
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31.01.2025
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Daiichi Sankyo Appoints Hiroyuki Okuzawa as Chief Executive Officer
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Daiichi Sankyo Company, Ltd (TSE: 4568) has appointed Hiroyuki Okuzawa, 62, to succeed Sunao Manabe, DVM, Ph.D. as Chief Executive Officer (CEO), effective April 1, 2025.
Dr. Manabe will transition from his current role of Representative Director, Executive Chairperson and CEO to Representative Director and Executive Chairperson while Mr. Okuzaw...
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31.01.2025
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TROPION-Lung12 Phase 3 Trial Initiated Evaluating DATROWAY® as Part of Adjuvant Regimen for Patients with Early-Stage Non-Small Cell Lung Cancer at High Risk of Relapse
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The first patient has been dosed in the TROPION-Lung12 phase 3 trial evaluating the efficacy and safety of adjuvant DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care in patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-pos...
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28.01.2025
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ENHERTU® Approved in the U.S. as First HER2 Directed Therapy for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following Disease Progression After One or More Endocrine Therapies
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined...
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17.01.2025
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DATROWAY® Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer
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DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
DATROWAY is a...
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13.01.2025
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Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH
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Daiichi Sankyo Company, Ltd (TSE: 4568) announced today that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody, gatipotuzumab. Such payment by Daiichi Sankyo satisfies all potential clinical, regulatory and sales milestone payments, as well as royalties of products...
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13.01.2025
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Datopotamab Deruxtecan Granted Priority Review in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
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Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung ca...
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24.12.2024
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Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn
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Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial....
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10.12.2024
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QuANTUM-Wild Phase 3 Trial of VANFLYTA® Initiated in Patients with Newly Diagnosed FLT3-ITD Negative AML
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The first patient has been dosed in the QuANTUM-Wild phase 3 trial evaluating Daiichi Sankyo’s (TSE: 4568) VANFLYTA® (quizartinib) in combination with standard intensive induction and consolidation chemotherapy followed by single-agent maintenance in adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML).
AML is an aggressive...
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09.12.2024
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Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
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Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR tyrosine kinase inhibito...
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06.12.2024
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Datopotamab Deruxtecan Demonstrated Meaningful Clinical Activity in Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer in TROPION-Lung05 and TROPION-Lung01 Pooled Analysis
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A pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). These data, along with progression-free and overall survival res...
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02.12.2024
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Daiichi Sankyo Highlights Progress Across Oncology Portfolio in Multiple Solid and Blood Cancers at ESMO Asia, SABCS and ASH
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Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple types of solid and blood cancers at the 2024 ESMO Asia Congress (#ESMOAsia24), San Antonio Breast Cancer Symposium (#SABCS24) and American Society of Hematology (#ASH24) Annual Meeting prior to its Science & Techn...
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13.11.2024
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Daiichi Sankyo to Showcase TURALIO® Research in Patients with Tenosynovial Giant Cell Tumor at CTOS
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Daiichi Sankyo (TSE: 4568) will highlight new clinical research and real-world data from seven abstracts for TURALIO® (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting.
TURALIO is the first and only oral systemic therapy approved in the U.S. for adult patients with tenosynovial giant cell tumor (TGCT) assoc...
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12.11.2024
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Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
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Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung canc...
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11.11.2024
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Alteogen enters into an Exclusive License Agreement to Develop and Commercialize Subcutaneous ENHERTU® Enabled by Alteogen's Hybrozyme™ Technology
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DAEJEON, South Korea, Nov. 10, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the company has entered into an exclusive license agreement with Daiichi Sankyo (TSE: 4568). Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme™ Techn...
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08.11.2024
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ENHERTU® Receives Prestigious 2024 Prix Galien USA Award for Best Biotechnology Product
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Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have been awarded The Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU® (fam-trastuzumab deruxtecan-nxki).
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly develo...
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30.10.2024
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Three Phase 3 Trials of Datopotamab Deruxtecan-Based Combinations Initiated in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer
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The first patients have been dosed in three global, randomized phase 3 trials evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd)-based combinations in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody dru...
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01.10.2024
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ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Who Have Received at Least One Line of Endocrine Therapy
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Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 wi...
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23.09.2024
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Datopotamab Deruxtecan Final Overall Survival Results Reported in Patients with Metastatic HR Positive, HER2 Low or Negative Breast Cancer in TROPION-Breast01 Phase 3 Trial
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Topline results from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metast...
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17.09.2024
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Patritumab Deruxtecan Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Doublet Chemotherapy in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer in HERTHENA-Lung02 Phase 3 Trial
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The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versu...
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15.09.2024
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DS-9606 Shows Promising Preliminary Clinical Activity in Patients with Advanced Solid Tumors
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Initial results from dose escalation in the first-in-human phase 1 trial of DS-9606 suggest early promising clinical activity in patients with advanced solid tumors known to express Claudin-6 (CLDN6). These data were presented today during a Proffered Paper session (610O) at the 2024 European Society for Medical Oncology (#ESMO24).
DS-9606 is an...
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13.09.2024
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ENHERTU® Showed Substantial Clinical Activity in Patients with HER2 Positive Metastatic Breast Cancer and Brain Metastases
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Results from the DESTINY-Breast12 phase 3b/4 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated substantial overall and intracranial clinical activity in a large cohort of patients with HER2 positive metastatic breast cancer who have brain metastases and received no more than two prior lines of therapy in the metastatic setting. Resu...
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09.09.2024
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Datopotamab Deruxtecan Showed Median Overall Survival of 14.6 Months in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial
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Detailed results from the TROPION-Lung01 phase 3 trial showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with...
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08.09.2024
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Novel Computational Pathology-Based TROP2 Biomarker for Datopotamab Deruxtecan Was Predictive of Clinical Outcomes in Patients with Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial
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Results from an exploratory analysis of the TROPION-Lung01 phase 3 trial showed TROP2 as measured by quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, was predictive of clinical outcomes in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who were treated with datopotamab deru...
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07.09.2024
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Ifinatamab Deruxtecan Continues to Demonstrate Promising Objective Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial
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Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). These data were featured today as part of a press conference and wil...
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