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Daiichi Sankyo Europe GmbH

Daiichi Sankyo Cancer Enterprise Milestones

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

June 2018

  • Pivotal phase 3 QuANTUM-R study results of single agent quizaritnib presented as a late-breaking oral presentation in the plenary program of the 2018 European Hematology Association (EHA) annual meeting
  • Pivotal phase 3 ENLIVEN study results of pexidartinib presented at the 2018 American Society of Clinical Oncology (ASCO) annual meeting

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 in North America, Japan and Europe
  • 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
  • Primary endpoing 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

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
  • 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 in North America, Europe and Japan

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 in the U.S. and Japan
  • 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 globally

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 Biotecnology’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 in Japan and South Korea

October 2017

  • Primary endpoint results were 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
  • 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®

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) was initiated
  • 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)
  • Daiichi Sankyo enters into a worldwide licensing agreement for Daiichi Sankyo’s novel RET inhibitor, DS-5010. Under the terms of the agreement, Daiichi Sankyo grants Boston Pharmaceuticals worldwide rights for the research, development, manufacturing and commercialization of DS-5010
  • 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

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 in Japan evaluating safety and efficacy of U3-1402 in HER3-positive metastatic or unresectable breast cancer

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)

October 2016

  • Patritumab selected for inclusion in I-SPY2 TRIAL in breast cancer
  • ENLIVEN Phase 3 study of pexidartinib in TGCT will continue to completion following enrollment discontinuation
  • Daiichi Sankyo enters into a preclinical lung cancer research collaboration with Dana-Farber Cancer Institute
  • Phase 3 QuANTUM-First study initiated examining safety and efficacy of quizartinib in newly-diagnosed FLT3-ITD-positive AML
  • Daiichi Sankyo enters into strategic collaboration with AgonOx, Inc. to develop undisclosed immune-oncology target
  • Daiichi Sankyo enters into cross-licensing and collaboration agreement with ZymeWorks to develop a bi-specific antibody therapeutic

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

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

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

July 2015

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

November 2014

Acquired Ambit Biosciences to expand oncology pipeline

February 2014

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

April 2012

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

August 2011

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

April 2011

Acquired Plexxikon Inc. for oncology pipeline and drug development

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

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

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

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