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Cancer Enterprise Global Pipeline

Daiichi Sankyo Cancer Enterprise Global Pipeline

As of January 31, 2018

These are investigational agents and are not approved by the FDA or any other worldwide regulatory agency as a treatment for any indication. Efficacy and safety have not been established. There is no guarantee that these investigational agents will become commercially available.

ADC Franchise

 

Compound Tumor Type Tumor Expressing Highest Phase of Development Location
DS-8201

Breast Cancer
(DESTINY-Breast01)
FDA Breakthrough Therapy
Designation
FDA Fast Track Designation

 

HER2

Phase 2

US, EU, Japan

DS-8201 Gastric Cancer
(DESTINY-Gastric01)
HER2 Phase 2 Japan, Asia
DS-8201 Colorectal Cancer HER2 Phase 2 preparation US, EU, Japan
DS-8201 Solid Tumors HER2 Phase 1 US, Japan

DS-8201
(in combination with
nivolumab)

Breast Cancer
Bladder Cancer
HER2 Phase 1 preparation US, EU
U3-1402

Breast Cancer

HER3

Phase 1

Japan

U3-1402 Non-Small Cell Lung Cancer HER3 Phase 1 preparation US, EU
DS-1062 Non-Small Cell Lung Cancer TROP2 Phase 1 US, Japan
DS-7300

Solid Tumors

B7-H3

Preclinical

--

DS-6157 Gastrointestinal Stromal Tumor

Undisclosed

Preclinical

--

DS-6000          Renal Cancer
       Ovarian Cancer

Undisclosed

Preclinical

--

 

AML Franchise

 

Compound Tumor Type Relevant
Pathway
Highest Phase of Development Location

Quizartinib (AC220)

Newly-Diagnosed Acute Myeloid Leukemia (AML)
(QuANTUM-First)

FLT3

Phase 3

US, EU,Asia

Quizartinib (AC220)

Relapsed/Refractory AML

(QuANTUM-R)
Fast Track Designation
Orphan Drug Designation

FLT3

Phase 3

US, EU, Asia

Quizartinib (AC220)

Relapsed/Refractory AML

FLT3

Phase 1

Japan

Quizartinib + DS-3032     Relapsed/Refractory AML
      Newly-Diagnosed AML
                     FLT3
                     MDM2
             Phase 1 preparation                        US
DS-3032

AML, Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndrome (MDS)

MDM2

Phase 1

US

DS-3032

Solid Tumors, Lymphoma

MDM2

Phase 1

Japan

DS-3032 Solid Tumors, Lymphoma MDM2 Phase 1 US
DS-3201

AML, ALL

EZH1/2

Phase 1

US

DS-3201

Non-Hodgkin’s Lymphoma

EZH1/2

Phase 1

Japan

PLX51107

AML, MDS, Lymphoma, Solid Tumors

BRD4

Phase 1

US

DS-1001

AML

IDH1

Preclinical

--

 

Breakthrough Science Franchise

 

Compound Tumor Type Relevant
Pathway
Highest Phase of Development Location

Pexidartinib (PLX3397)

Tenosynovial Giant Cell Tumor (TGCT)* FDA Breakthrough Designation
Orphan Drug Designation

CSF-1R

Phase 3

US / EU

Patritumab (U3-1287)

Head and Neck Cancer

HER3

Phase 2

EU

DS-1647

Glioblastoma SAKIGAKE Designation

Oncolytic HSV-1

Phase 2

Japan

DS-1205 (in combination with osimertinib) Non-Small Cell Lung Cancer AXL Phase 1 preparation US
DS-1001 Gliomas IDH1 Phase 1 Japan
PLX2853 Solid Tumors BRD4 Phase 1 US
PLX73086 TGCT CSF-1R Phase 1 US
PLX7486

Solid Tumors

FMS/TRK

Phase 1

US

PLX8394

Solid Tumors

BRAF

Phase 1

US

PLX9486

Solid Tumors

KIT

Phase 1

US

*Tenosynovial giant cell tumor (TGCT), which includes pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS).

PP-US-ON-0149
01/18

 

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