Daiichi Sankyo Company, Ltd.

132 articles with Daiichi Sankyo Company, Ltd.

• Preclincal Results of Baoyuan's Next-Generation ROS1/NTRK Inhibitor AB-106 Published in Nature Communications

  9/25/2019

  The preclinical results of AB-106, an investigational next generation ROS1/NTRK dual inhibitor exclusively in-licensed by AnHeart Therapeutics, a wholly-owned subsidiary of Baoyuan Biopharmaceuticals Technology Co., Ltd. from Daiichi Sankyo Company, Limited, were published online by the peer-reviewed academic journal Nature Communications on August 9, 2019.[1]

• Updated Phase 1 Data for Daiichi Sankyo's U3-1402 in Patients with EGFR Mutated NSCLC Presented at 2019 World Conference on Lung Cancer

  9/10/2019

  Daiichi Sankyo Company, Limited announced the presentation of updated phase 1 data for U3-1402, an investigational HER3 targeting antibody drug conjugate (ADC), in 30 patients with metastatic EGFR mutated, TKI resistant non-small cell lung cancer (NSCLC).

• Updated Clinical Results and New Biomarker Analyses Presented for Daiichi Sankyo's DS-1062 in Patients with Advanced NSCLC at 2019 World Conference on Lung Cancer

  9/10/2019

  Daiichi Sankyo Company, Limited announced the presentation of updated phase 1 clinical results and new biomarker data for DS-1062, an investigational TROP2 targeting antibody drug conjugate (ADC), in 52 unselected patients with heavily pretreated advanced non-small cell lung cancer (NSCLC).

• Daiichi Sankyo Advances [Fam-] Trastuzumab Deruxtecan (DS-8201) in Japan with Regulatory Submission in HER2 Positive Metastatic Breast Cancer

  9/9/2019

  Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer.

• Updated Clinical Results and New Translational Research Data for Daiichi Sankyo's ADCs U3-1402 and DS-1062 to be Presented at the 2019 World Conference on Lung Cancer

  8/21/2019

  Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that updated results and new translational research data from two phase 1 studies evaluating investigational antibody drug conjugates (ADCs) U3-1402 and DS-1062 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) will be presented at the 2019 IASLC World Conference on Lung Cancer (#WCLC19), to be held September 7-10, 2019 in Barcelona, Spain.

• FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor

  8/3/2019

  Daiichi Sankyo Company, Limited announced that the U.S. Food and Drug Administration approved TURALIO™ as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

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

  6/21/2019

  Daiichi Sankyo Company, Limited announced that the company received a Complete Response Letter from the U.S. Food and Drug Administration for the New Drug Application of quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia.

• Daiichi Sankyo's VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML

  6/18/2019

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

• 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

  6/2/2019

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

• 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

  6/1/2019

  Daiichi Sankyo Company, Limited announced that new data from a pooled analysis of the phase 3 ENLIVEN study and phase 1 extension study showed continued treatment with pexidartinib resulted in an increased tumor response rate in TGCT patients.

• 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

  5/31/2019

  Daiichi Sankyo Company, Limited announced that preliminary results from the dose escalation part of the phase 1 study with U3-1402, an investigational and potential first-in-class HER3 targeting antibody drug conjugate (ADC), in 23 patients with metastatic EGFR mutated, TKI resistant non-small cell lung cancer, presented during an Oral Symposium at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

• Daiichi Sankyo Data Presentations at 2019 ASCO Annual Meeting Highlight Depth of ADC Pipeline and Promises of Oncology Portfolio

  5/15/2019

  Daiichi Sankyo Company, Limited announced that it will present new data for several investigational compounds in the Daiichi Sankyo oncology pipeline at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 31 to June 4 in Chicago.

• FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo's Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor

  5/14/2019

  Daiichi Sankyo Company, Limited announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that the demonstrated benefit of pexidartinib outweighs the risks in the treatment of adult patients with symptomatic TGCT, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.

• Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

  5/14/2019

  Daiichi Sankyo Company, Limited announced the outcome of the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee to discuss the company's New Drug Application for quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia.

• Exelixis’ Collaborator Daiichi Sankyo Launches MINNEBRO® (Esaxerenone) Tablets in Japan

  5/13/2019

  First commercial sale triggers $20 million milestone payment to Exelixis

• 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

  4/29/2019

  20.7 months median duration of response achieved in patients with HER2 positive metastatic breast cancer previously treated with T-DM1

• Daiichi Sankyo Selects Lead Candidate Built on Zymeworks’ Azymetric™ Bispecific Platform

  4/25/2019

  One of three bispecific immuno-oncology therapeutics being developed under the two companies’ collaboration agreements

• 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