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Oncology History Main Article

Daiichi Sankyo Cancer Enterprise Milestones

Oncology History

  • May 2019

    Pivotal phase 2 DESTINY-Breast01 trial of [fam-] trastuzumab deruxtecan (DS-8201) met primary endpoint

  • 2019
    April 2019

    Two manuscripts published in The Lancet Oncology report on the long-term phase 1 safety and efficacy results of [fam-] trastuzumab deruxtecan (DS-8201) in heavily pretreated patients with HER2 positive metastatic breast cancer and gastric cancer

  • April 2019

    Daiichi Sankyo exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on Zymeworks’ Azymetric™ and EFECT™ platforms

  • 2019
    April 2019

    Valemetostat (DS-3201) receives SAKIGAKE Designation for treatment of patients with relapsed/refractory peripheral T-cell lymphoma from Japan MHLW

  • April 2019

    EMA validates marketing authorization application for pexidartinib for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery

  • 2019
    March 2019

    Daiichi Sankyo and AstraZeneca announce global development and commericialization collaboration for [fam-] trastuzumab deruxtecan (DS-8201)

  • March 2019

    Daiichi Sankyo confirms plans to accelerate BLA submission to FDA for [fam-] trastuzumab deruxtecan (DS-8201) in HER2 positive mestastic breast cancer post T-DM1

  • 2019
    February 2019

    FDA accepts NDA and grants Priority Review for pexidartinib for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery

  • January 2019

    Pivotal phase 3 DESTINY-Breast04 study of [fam-] trastuzumab deruxtecan (DS-8201) in HER2 low metastatic breast cancer initiated

  • 2018
    December 2018

    Phase 1 study initiated to evaluate the safety and activity of quizartinib and milademetan (DS-3032) in patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy

  • December 2018

    Daiichi Sankyo out-licenses ROS1/NTRK inhibitor DS-6051 to AnHeart Therapeutics

  • 2018
    December 2018

    Daiichi Sankyo and Sarah Cannon Research Institute announce a strategic oncology development collaboration

  • December 2018

    Updated efficacy and safety results from ongoing phase 1/2 study of U3-1402 presented at the 2018 San Antonio Breast Cancer Symposium (SABCS)

  • 2018
    December 2018

    Updated safety and efficacy data from the ongoing phase 1 study of [fam-] trastuzumab deruxtecan presented for a subgroup of patients with heavily pretreated HER2 low expressing metastatic breast cancer at the 2018 San Antonio Breast Cancer Symposium (SABCS)

  • December 2018

    Comprehensive analyses of overall survival from the pivotal phase 3 QuANTUM-R study of quizartinib presented at the American Society of Hematology (ASH) annual meeting

  • 2018
    November 2018

    Daiichi Sankyo enters into an agreement with Roche to collaborate on the development of a new HER2 low companion diagnostic test

  • November 2018

    FDA accepts NDA and grants Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD AML

  • 2018
    November 2018

    EMA validates for review and grants accelerated assessment to the MAA for quizartinib for the treatment of adults with relapsed or refractory AML which is FLT3-ITD positive

  • October 2018

    Daiichi Sankyo enters into a clinical trial collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer, Inc. to evaluate the combination of [fam-] trastuzumab deruxtecan (DS-8201) 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

  • 2018
    October 2018

    Updated phase 1 safety and efficacy data of [fam-] trastuzumab deruxtecan (DS-8201) presented for a subgroup of patients with heavily pretreated HER2 expressing colorectal cancer at the 2018 European Society for Medical Oncology (ESMO)

  • October 2018

    First-in-human phase 1 study initiated assessing the safety and tolerability of DS-1205 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)

  • 2018
    October 2018

    NDA submitted to Japan’s Ministry of Health, Labour and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD AML

  • October 2018

    Axicabtagene ciloleucel (formerly KTE-C19) granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL)

  • 2018
    September 2018

    DESTINY-Breast03 and DESTINY-Breast02, two global phase 3 studies evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201), initiated in patients with previously treated HER2 positive unresectable and/or metastatic breast cancer

  • September 2018

    Updated phase 1 safety and efficacy data for [fam-] trastuzumab deruxtecan (DS-8201) for a subgroup of patients with heavily pretreated HER2 mutated or HER2 expressing non-small cell lung cancer (NSCLC) presented at the IASLC 19th World Conference on Lung Cancer

  • 2018
    September 2018

    Daiichi Sankyo enters into a clinical trial collaboration agreement with a subsidiary of Merck & Co to evaluate the combination of DS-8201 and KEYTRUDA® (pembrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC)

  • September 2018

    Quizartinib granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of FLT3-mutated AML

  • 2018
    August 2018

    Quizartinib granted Breakthrough Therapy designation by the FDA for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML)

  • July 2018

    Daiichi Sankyo enters into a worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody gatipotuzumab (formerly PankoMab-GEX®), building on a previous 2017 option agreement.

  • 2018
    June 2018

    Pivotal phase 3 QuANTUM-R study results of single agent quizartinib presented as a late-breaking oral presentation in the plenary program of the 2018 European Hematology Association (EHA) annual meeting

  • June 2018

    Pivotal phase 3 ENLIVEN study results of pexidartinib presented at the 2018 American Society of Clinical Oncology (ASCO) annual meeting

  • 2018
    May 2018

    Phase 2 study evaluating the safety and efficacy of DS-8201 in patients with unresectable and/or metastatic non-squamous HER2-overexpressing or HER2-mutated non-small cell lung cancer that has progressed after one or more prior therapies initiated

  • May 2018

    Daiichi Sankyo and Zymeworks announced they entered into a new license agreement building upon their 2016 cross-licensing and collaboration agreement. Under the terms of the second agreement, Daiichi Sankyo will acquire licenses to Zymeworks’ Azymetric™ and EFECT™ technology platforms to develop two additional bispecific antibody therapeutics

  • 2018
    May 2018

    Primary endpoint results were announced for pivotal QuANTUM-R phase 3 study of single agent quizartinib compared to salvage chemotherapy in patients with relapsed/refractory AML with FLT3-ITD mutations

  • April 2018

    Daiichi Sankyo and DarwinHealth enter into a research agreement providing Daiichi Sankyo with exclusive access to DarwinHealth’s proprietary novel cancer target database in order to identify potential new targets for cancer drug development

  • 2018
    March 2018

    DS-8201 granted SAKIGAKE Designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer

  • March 2018

    Phase 2 study evaluating the safety and efficacy of DS-8201 in patients with HER2 expressing advanced colorectal cancer who have received at least two prior lines of standard treatment initiated

  • 2018
    February 2018

    Phase 1 study evaluating the safety and efficacy of DS-1062 in patients with unresectable advanced non-small cell lung cancer (NSCLC) refractory to or relapsed following standard treatment or for whom no standard treatment available initiated

  • February 2018

    Phase 1 study evaluating the safety and efficacy of U3-1402 in patients with metastatic EGFR-mutated NSCLC with disease progression while taking an EGFR tyrosine kinase inhibitor (TKI) initiated

  • 2017
    December 2017

    Daiichi Sankyo and Puma Biotechnology enter into a preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSK) to explore the combination of Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 and Puma Biotechnology’s irreversible pan-HER inhibitor neratinib in HER2 mutated or HER2 positive solid tumors.

  • November 2017

    Pivotal phase 2 DESTINY-Gastric01 study evaluating the safety and efficacy of DS-8201 in patients with HER2 positive advanced gastric or gastroesophageal junction adenocarcinoma resistant or refractory to trastuzumab initiated

  • 2017
    October 2017

    Primary endpoint results announced for pivotal phase 3 placebo-controlled ENLIVEN study in patients with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection is potentially associated with worsening functional limitation or severe morbidity

  • October 2017

    Daiichi Sankyo enters into an option agreement with Glycotope GmbH for future strategic collaboration and licensing to develop an ADC by combining Daiichi Sankyo’s proprietary ADC technology with Glycotope’s investigational tumor-associated TA-MUC1 antibody PankoMab-GEX®

  • 2017
    September 2017

    Daiichi Sankyo and The University of Texas MD Anderson Cancer Center enter into a multi-year collaboration focused on accelerating the development of novel therapies for acute myeloid leukemia (AML)

  • August 2017

    Pivotal phase 2 DESTINY-Breast01 evaluating the safety and efficacy of DS-8201 in patients with HER2 positive unresectable and/or metastatic breast cancer who are resistant or refractory to ado-trastuzumab emtansine (T-DM1) initiated

  • 2017
    August 2017

    DS-8201 granted Breakthrough Therapy Designation by the FDA for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1)

  • August 2017

    Daiichi Sankyo enters into a worldwide licensing agreement for Daiichi Sankyo’s novel RET inhibitor, DS-5010, with Boston Pharmaceuticals.

  • 2017
    August 2017

    Daiichi Sankyo and Bristol-Myers Squibb announced a collaborative clinical trial to evaluate the combination of Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2 expressing metastatic breast and urothelial (bladder) cancers

  • July 2017

    Daiichi Sankyo signs an agreement with Max Planck Innovation GmbH and the Lead Discovery Center GmbH providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center

  • 2017
    April 2017

    Daiichi Sankyo announced an initial 15 billion yen investment to optimize and enhance its manufacturing capabilities to support its growing antibody drug conjugate (ADC) pipeline

  • January 2017

    Phase 1 study initiated evaluating safety and efficacy of U3-1402 in HER3 positive metastatic or unresectable breast cancer

  • 2016
    December 2016

    Daiichi Sankyo enters into strategic partnership with DarwinHealth to deploy a quantitative systems biology discovery platform to prioritize Daiichi Sankyo Cancer Enterprise compounds for development

  • November 2016

    DS-8201 granted Fast Track designation by the FDA for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

  • 2016
    October 2016

    Daiichi Sankyo enters into cross-licensing and collaboration agreement with ZymeWorks to develop a bi-specific antibody therapeutic

  • October 2016

    Daiichi Sankyo enters into a preclinical lung cancer research collaboration with Dana-Farber Cancer Institute

  • 2016
    October 2016

    Patritumab selected for inclusion in I-SPY2 TRIAL in breast cancer

  • October 2016

    Daiichi Sankyo enters into strategic collaboration with AgonOx, Inc. to develop undisclosed immune-oncology target

  • 2016
    October 2016

    Phase 3 QuANTUM-First study initiated examining safety and efficacy of quizartinib in newly-diagnosed FLT3-ITD-mutated AML

  • April 2016

    Antoine Yver, MD, MSc, appointed to Global Head, Oncology Research and Development, responsible for leading global research and development across the oncology therapeutic area

  • 2016
    March 2016

    Daiichi Sankyo announced 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology"

  • November 2015

    Cobimetinib plus Zelboraf received FDA approval. Began co-promotion in the US with Genentech

  • 2015
    October 2015

    Pexidartinib granted Breakthrough Therapy Designation by the FDA for the treatment of tenosynovial giant cell tumor (TGCT)

  • August 2015

    Generic name for PLX3397, pexidartinib, recommended by the International Nonproprietary Names (INN) for Pharmaceutical Substances

  • 2015
    July 2015

    PLX3397 phase 1 extension data published in The New England Journal of Medicine

  • November 2014

    Acquired Ambit Biosciences to expand oncology pipeline

  • 2014
    February 2014

    PLX3397 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA)

  • April 2012

    Launched Ranmark® (denosumbab) in Japan for treatment of bone complications stemming from multiple myeloma and bone metastases from solid tumors.

  • 2011
    August 2011

    Received FDA approval of Zelboraf® (vemurafenib). Co-promotion with Genentech began.

  • April 2011

    Acquired Plexxikon Inc. for oncology pipeline and drug development

  • 2009
    March 2009

    Quizartinib granted Orphan Drug Designation by the FDA (received by Ambit Biosciences prior to becoming part of Daiichi Sankyo)

  • May 2008

    Acquired U3 Pharma, a company with a pipeline of targeted antibody therapeutics for cancer

  • 1995
    1995

    Received approval of irinotecan in Japan, the first chemotherapy to demonstrate survival benefits in colorectal cancer

  • 1985

    Launched the first natural-type interferon beta preparation for brain tumor and skin cancer in Japan

  • 1977
    1977

    Launched Krestin® (Polysaccharide-K) in Japan to treat digestive, lung and breast cancer

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Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do.

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