Daiichi Sankyo Company, Ltd.

115 articles with Daiichi Sankyo Company, Ltd.

• Daiichi Sankyo's EZH1/2 Dual Inhibitor Valemetostat (DS-3201) Receives SAKIGAKE Designation for Treatment of Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from Japan MHLW

  4/9/2019

  SAKIGAKE Designation will provide development support and accelerated review of valemetostat, an investigational and potential first-in-class EZH1/2 dual inhibitor, for relapsed/refractory peripheral T-cell lymphoma (PTCL)

• Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

  4/4/2019

  Daiichi Sankyo Company, Limited announced that the U.S. Food and Drug Administration has extended the review period for the New Drug Application of quizartinib, an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia.

• 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

  3/28/2019

  BLA submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with T-DM1 to be accelerated to first half of fiscal year 2019

• Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo's HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201)

  3/28/2019

  Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates; AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia

• Daiichi Sankyo Shifts Several Top Leaders to New Roles for Company's Launch into its Next Growth Phase

  2/22/2019

  Dr. Junichi Koga to become new global Head of Research & Development Unit and Co-Chair of the company's Global Executive Meeting of R&D (GEMRAD), the top decision-making body in R&D

• 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

  2/5/2019

  If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant cell tumor (TGCT) when associated with severe morbidity or functional limitations, and not amenable to improvement with surgery

• Exelixis’ Collaborator Daiichi Sankyo Receives Regulatory Approval For MINNEBRO™ (Esaxerenone) Tablets for the Treatment of Hypertension in Japan

  1/8/2019

  Exelixis, Inc. announced that its partner Daiichi Sankyo Company, Ltd. received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for esaxerenone tablets, MINNEBRO™ 1.25 mg, 2.5 mg, and 5 mg, as a treatment for patients with hypertension

• Roivant Sciences and Daiichi Sankyo Enter into Broad Pipeline Partnership

  12/19/2018

  Under the terms of the agreement, Roivant will have the option to obtain exclusive licenses for certain development programs from Daiichi Sankyo on prespecified terms contingent on phase of development.

• Daiichi Sankyo Initiates First Novel-Novel Combination Study of Two Investigational Agents within its AML Franchise in Patients with AML

  12/19/2018

  Phase 1 study initiated to evaluate the combination of a FLT3 inhibitor, quizartinib, and an MDM2 inhibitor, milademetan (DS-3032), in patients with relapsed/refractory FLT3-ITD AML or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy

• Daiichi Sankyo and Sarah Cannon Research Institute Launch Strategic Collaboration to Develop Novel Cancer Therapies

  12/10/2018

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

• 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)

  12/8/2018

  Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 44.2 percent and a disease control rate of 79.1 percent in 43 evaluable patients with heavily pretreated HER2 low metastatic breast cancer

• 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)

  12/5/2018

  Updated efficacy and safety results presented from ongoing phase 1/2 study with U3-1402, an investigational and potential first-in-class HER3-targeting antibody drug conjugate (ADC), in patients with heavily pretreated HER3-positive metastatic breast cancer

• 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

  12/3/2018

  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 refractory or relapsed within six months of first remission, a very aggressive subtype of the disease associated with poor prognosis

• Daiichi Sankyo and Roche to Collaborate on New HER2 Low Companion Diagnostic Test

  11/27/2018

  Daiichi Sankyo Company, Limited announced today that it has entered into an agreement with Roche to collaborate on the development of a new HER2 low companion diagnostic test.

• Vernalis Research, a Ligand Company, Achieves Success Milestones in Collaboration with Daiichi Sankyo

  11/13/2018

  The research utilizes Vernalis' fragment and structure-based drug discovery platform for two undisclosed oncology targets.

• 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

  11/5/2018

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

• Daiichi Sankyo Announces Clinical Research Collaboration with Merck KGaA, Darmstadt, Germany and Pfizer

  10/25/2018

  Collaboration agreement to evaluate the combination of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in combination with the checkpoint inhibitor avelumab and/or an investigational Merck KGaA, Darmstadt, Germany DNA damage response (DDR) inhibitor, in patients with HER2 expressing or mutated solid tumors.

• 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

  10/21/2018

  Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 15.8 percent and a disease control rate of 84.2 percent in 19 evaluable patients with heavily pretreated colorectal cancer with varying levels of HER2 expression

• Daiichi Sankyo Initiates Phase 1 Study of AXL Inhibitor DS-1205 in Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

  10/18/2018

  Daiichi Sankyo Company, Ltd. (hereafter, Daiichi Sankyo) announced that the first patient has been dosed in a first-in-human phase 1 study assessing the safety and tolerability of DS-1205, a highly selective investigational AXL inhibitor, in combination with gefitinib in patients with metastatic or unresectable epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have progressed on therapy with tyrosine kinase inhibitors (TKIs).

• Daiichi Sankyo Initiates Two Phase 3 Trials of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Positive Metastatic Breast Cancer including Head-to-Head Versus T-DM1 and Post-T-DM1 Study

  9/25/2018

  DESTINY-Breast03 to compare [fam-] trastuzumab deruxtecan (DS-8201) versus ado-trastuzumab emtansine (T-DM1) in HER2 positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and taxane