News from daiichi sankyo company, limited A wide array of domestic and global news stories; news topics include politics/government, business, technology, religion, sports/entertainment, science/nature, and health/lifestyle. Articles that appear in this section may be written in English or other languages

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18 Jun, 2019, 13:00 BST Daiichi Sankyo's VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML

- VANFLYTA® (quizartinib) is a FLT3 inhibitor MHLW-approved based on a survival benefit compared to salvage chemotherapy in adult patients with...


02 Jun, 2019, 13:00 BST Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

- First-in-human results presented for DS-1062, an investigational TROP2 targeting ADC, in patients with advanced NSCLC where no standard treatment...


01 Jun, 2019, 13:00 BST Daiichi Sankyo's Pexidartinib Demonstrated Further Improvement with Continued Treatment of Tenosynovial Giant Cell Tumor Patients in New Long-Term Analysis Presented at 2019 ASCO Annual Meeting

- New pooled data demonstrated continued treatment with pexidartinib increased tumor response rate in patients with tenosynovial giant cell tumor...


31 May, 2019, 13:00 BST Daiichi Sankyo Presents Preliminary Phase 1 Data for HER3 Targeting ADC U3-1402 in Patients with EGFR Mutated Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

- First phase 1 results presented for U3-1402, a potential first-in-class HER3 targeting antibody drug conjugate (ADC), in patients with metastatic...


29 Apr, 2019, 23:30 BST Daiichi Sankyo Announces Two Lancet Oncology Publications of Phase 1 Dose Expansion Results of [Fam-] Trastuzumab Deruxtecan in HER2 Positive Metastatic Breast and Gastric Cancer

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced the publication of two manuscripts in The Lancet Oncology ...


03 Apr, 2019, 13:03 BST EMA Validates Daiichi Sankyo's Marketing Authorization Application for Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating, Non-Malignant Tumor

- Application based on results of phase 3 ENLIVEN study, the first placebo-controlled study of a systemic investigational therapy in patients with...


28 Mar, 2019, 23:30 GMT Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo's HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201)

- Collaboration combines Daiichi Sankyo's scientific and technological excellence with AstraZeneca's global experience and resources in oncology to...


28 Mar, 2019, 23:29 GMT Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1

- BLA submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with T-DM1 to be...


19 Mar, 2019, 09:30 GMT Data from the Non-interventional EMIT-AF/VTE Study Shows Low Thromboembolic and Bleeding Event Rates in Unselected Elderly AF/VTE Patients on Oral, Once-daily LIXIANA®▼ Undergoing Diagnostic or Therapeutic Procedures

In 2019, the Edoxaban Clinical Research Programme will deliver new evidence on LIXIANA®▼ (edoxaban) use in clinical practice. EMIT-AF/VTE is one of...


19 Mar, 2019, 08:58 GMT CLEAR Wisdom Demonstrated First-in-class, Oral, Once-daily, ACL Inhibitor Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP

Daiichi Sankyo Europe GMbH (hereafter, 'Daiichi Sankyo') and Esperion (NASDAQ: ESPR) today announced that the Phase 3 results from CLEAR Wisdom of...


18 Mar, 2019, 14:00 GMT Daiichi Sankyo Presents Positive Results of the First Randomised, Controlled Trial of Uninterrupted Oral, Once-daily LIXIANA®▼ (edoxaban) in Atrial Fibrillation Patients Undergoing Catheter Ablation

ELIMINATE-AF is the first set of data presented in 2019 from the Edoxaban Clinical Research Programme, which will deliver new evidence to support the ...


28 Feb, 2019, 12:00 GMT Daiichi Sankyo Europe and Esperion Announce Validation of the Marketing Authorisation Application (MAA) for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Fixed Dose Combination Tablet

Application is based on results of a robust development programme, which demonstrated that bempedoic acid was well tolerated and efficacious for...


05 Feb, 2019, 13:00 GMT FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor

- If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant cell tumor (TGCT) when associated with...


14 Jan, 2019, 13:00 GMT Daiichi Sankyo Initiates Pivotal Phase 3 Trial of [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Low Metastatic Breast Cancer

- DESTINY-Breast04 to evaluate [fam-] trastuzumab deruxtecan (DS-8201) versus investigator's choice in HER2 low, unresectable and/or metastatic...


07 Jan, 2019, 07:00 GMT Daiichi Sankyo Europe Enters into European Licensing Agreement with Esperion for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet

Daiichi Sankyo Europe will market oral bempedoic acid and bempedoic acid / ezetimibe combination tablet in the European Economic Area and Switzerland ...


19 Dec, 2018, 13:00 GMT Daiichi Sankyo Initiates First Novel-Novel Combination Study of Two Investigational Agents within its AML Franchise in Patients with AML

- Phase 1 study initiated to evaluate the combination of a FLT3 inhibitor, quizartinib, and an MDM2 inhibitor, milademetan (DS-3032), in patients...


10 Dec, 2018, 13:00 GMT Daiichi Sankyo and Sarah Cannon Research Institute Launch Strategic Collaboration to Develop Novel Cancer Therapies

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute announced today a strategic oncology development...


08 Dec, 2018, 13:00 GMT Daiichi Sankyo Presents Updated Phase 1 Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Low Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS)

- Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 44.2...


05 Dec, 2018, 23:00 GMT Daiichi Sankyo Presents Updated Phase 1 Data for U3-1402 in Patients with HER3-Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS)

- Updated efficacy and safety results presented from ongoing phase 1/2 study with U3-1402, an investigational and potential first-in-class...


03 Dec, 2018, 15:00 GMT Comprehensive Analyses from Pivotal Phase 3 QuANTUM-R Study Demonstrate Consistent Overall Survival Benefit of Daiichi Sankyo's FLT3 Inhibitor Quizartinib in Patients with Relapsed/Refractory FLT3-ITD AML

- Quizartinib is the first FLT3 inhibitor to demonstrate a survival benefit in a randomized phase 3 study in patients with FLT3-ITD AML, which was...


27 Nov, 2018, 13:00 GMT Daiichi Sankyo and Roche to Collaborate on New HER2 Low Companion Diagnostic Test

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into an agreement with Roche to collaborate on the...


22 Nov, 2018, 07:00 GMT FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

- Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML and follows recent ...


05 Nov, 2018, 07:00 GMT EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo's FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

- Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML - Quizartinib is...


25 Oct, 2018, 13:00 BST Daiichi Sankyo Announces Clinical Research Collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate [Fam-] Trastuzumab Deruxtecan (DS-8201) with Avelumab and a DNA Damage Response Inhibitor in Patients with HER2 Expressing and Mutated Solid Tumors

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a clinical trial collaboration agreement with Merck...


21 Oct, 2018, 11:45 BST Daiichi Sankyo Presents Updated Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Expressing Advanced Colorectal Cancer at 2018 European Society for Medical Oncology (ESMO) Congress

- Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 15.8...