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Daiichi Sankyo Europe GmbH

Daiichi Sankyo Cancer Enterprise Milestones

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 Institue
  • 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

1977

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