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

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

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

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

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

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

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

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

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

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

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)

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)

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

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

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.

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

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

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

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

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

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

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®

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

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

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

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

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).

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

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

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

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

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

Acquired Ambit Biosciences to expand oncology pipeline

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

Acquired Plexxikon Inc. for oncology pipeline and drug development

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

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