Daiichi Sankyo Company, Limited Announced That Enhertu (Trastuzumab Deruxtecan), A Her2 Directed Antibody Drug Conjugate (Adc), Received The Prime Minister&Rsquo;S Award At The 9Th Technology Management And Innovation Awards Hosted By The Japan Techno-Economics Society (Jates).The Technology Management And Innovation Awards Were Established In 2012 With The Objective Of Contributing To The Development Of The Nation&Rsquo;S Economy, Social Changes, And The Promotion Of A Global Competitive Edge By Widely Introducing Technological Innovations Originating In Japan. This Year Marks The 9Th Year Of The Award.&Ldquo;It Is A Great Honor For Us To Receive Such A Prestigious Award,&Rdquo; Said Sunao Manabe, Representative Director, President And Ceo Of Daiichi Sankyo Company, Limited. "We Have Been Evaluated For Our Wide Array Of Efforts And Initiatives To Offer Promising Treatment Options To Patients With Cancer For Whom The Range Of Therapies Is Limited. We Will Continue To Work Hard To Deliver Therapies For More Indications To Patients Around The World.&Rdquo;Daiichi Sankyo Received This Award As A Result Of Several Key Accomplishments Achieved Through The Comprehensive Research And Development Program For Enhertu. These Accomplishments Included The Development Of A Management System That Enabled Rapid Decision-Making For The Technological Research And Development Of Enhertu; Collaborating With Academic And Healthcare Institutions To Create Quality Non-Clinical And Clinical Data That Met International Standards To Secure Regulatory Approvals; Exploring New And Innovative Ways To Deliver Enhertu To Patients As Quickly As Possible; And Developing A Successful Formula To Minimize Quality Risk. Enhertu (5.4 Mg/Kg; T-Dxd; Trastuzumab Deruxtecan; Fam-Trastuzumab Deruxtecan-Nxki In The Us Only) Is Approved In The Us Under Accelerated Approval, In The Eu Under Conditional Marketing Authorization, And In Japan Under The Conditional Early Approval System For The Treatment Of Adult Patients With Unresectable Or Metastatic Her2 Positive Breast Cancer Who Have Received Two Or More Prior Anti-Her2 Based Regimens In The Metastatic Setting Based On The Results From The Destiny-Breast01 Trial.Enhertu (6.4 Mg/Kg) Is Also Approved In The Us And Japan For The Treatment Of Patients With Her2 Positive Unresectable Advanced Or Recurrent Gastric Cancer Who Have Received A Prior Trastuzumab-Based Regimen Based On The Results From The Destiny-Gastric01 Trial.Enhertu Is Approved In The Us With Boxed Warnings For Interstitial Lung Disease And Embryo-Fetal Toxicity.A Comprehensive Development Program Is Underway Globally With Nine Pivotal Trials Evaluating The Efficacy And Safety Of Enhertu Monotherapy Across Multiple Her2 Targetable Cancers Including Breast, Gastric And Lung Cancers. Trials In Combination With Other Anticancer Treatments, Such As Immunotherapy, Are Also Underway.In May 2020, Enhertu Received Breakthrough Therapy Designation (Btd) In The Us For The Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Have A Her2 Mutation And With Disease Progression On Or After Platinum-Based Therapy.Enhertu (T-Dxd; Trastuzumab Deruxtecan; Fam-Trastuzumab Deruxtecan-Nxki In The Us Only) And Datopotamab Deruxtecan (Dato-Dxd; Ds-1062) Are Two Lead Dxd Adcs In The Oncology Pipeline Of Daiichi Sankyo, And The Most Advanced Programs In Astrazeneca&Rsquo;S Adc Scientific Platform.Each Adc Is Engineered Using Daiichi Sankyo&Rsquo;S Proprietary And Portable Dxd Adc Technology To Target And Deliver Chemotherapy Inside Cancer Cells That Express A Specific Cell Surface Antigen. Both Enhertu (A Her2 Directed Adc) And Datopotamab Deruxtecan (A Trop2 Directed Adc) Consist Of A Monoclonal Antibody Attached To A Topoisomerase I Inhibitor Payload, An Exatecan Derivative, Via A Stable Tetrapeptide-Based Cleavable Linker.Daiichi Sankyo And Astrazeneca Entered Into A Global Collaboration To Jointly Develop And Commercialize Enhertu In March 2019, And Datopotamab Deruxtecan In July 2020, Except In Japan Where Daiichi Sankyo Maintains Exclusive Rights For Each Adc. Daiichi Sankyo Is Responsible For Manufacturing And Supply Of Enhertu And Datopotamab Deruxtecan.Datopotamab Deruxtecan Is An Investigational Agent That Has Not Been Approved For Any Indication In Any Country. Safety And Efficacy Have Not Been Established.
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