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Cancer Enterprise Global Pipeline

Daiichi Sankyo Cancer Enterprise Global Pipeline

As of July 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.

Investigational ADC Franchise

 

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

Breast Cancer (vs. T-DM1)

DESTINY-Breast03

 

HER2

Phase 3

US, EU, Japan, Asia

DS-8201

Breast Cancer (post T-DM1)

DESTINY-Breast02

 

Breast Cancer (post T-DM1)

DESTINY-Breast01

FDA Breakthrough Therapy Designation

FDA Fast Track Designation

HER2

Phase 3

US, EU, Japan, Asia

DS-8201

Gastric Cancer (post-trastuzumab)
(DESTINY-Gastric01)SAKIGAKE Designation

HER2 Phase 2 Japan, Asia
DS-8201 Colorectal Cancer HER2 Phase 2 US, EU, Japan
DS-8201 Non-Small Cell Lung Cancer HER2 Phase 2 US, EU, Japan
DS-8201 [in combination with nivolumab]

Breast Cancer

Bladder Cancer
HER2 Phase 1 US, EU
DS-8201 Solid Tumors HER2 Phase 1 US, Japan
U3-1402

Breast Cancer

HER3

Phase 1

Japan

U3-1402 Non-Small Cell Lung Cancer HER3 Phase 1 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

--

TA-MUC1 Solid Tumor TA-MUC1 Discovery --

 

Investigational AML Franchise

 

Compound Tumor Type Relevant
Pathway
Highest Phase of Development Location

Quizartinib

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

FLT3

Phase 3

US, EU,Asia

Quizartinib

Relapsed/Refractory AML

QuANTUM-R
FDA Breakthrough Designation  
FDA Fast Track Designation
Orphan Drug Designation In US and EU

FLT3

Phase 3

US, EU, Asia

Quizartinib

Relapsed/Refractory AML

FLT3

Phase 2

Japan

Quizartinib + Milademetan

(DS-3032)
Relapsed/Refractory AML
Newly-Diagnosed AML
FLT3
MDM2
Phase 1 US
Milademetan
(DS-3032)[single agent/combination with azacitabine]

AML, Myelodysplastic Syndrome (MDS)

MDM2

Phase 1

US

Milademetan
(DS-3032)

Solid Tumors, Lymphoma

MDM2

Phase 1

Japan

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

AML, ALL

EZH1/2

Phase 1

US

DS-3201

 

Adult T-cell leukemia/lymphoma
Peripheral T-cell lymphoma

EZH1/2

Phase 1

Japan

PLX51107

AML, MDS, Solid Tumors

BRD4

Phase 1

US

DS-1001

AML

IDH1

Preclinical

--

 

Investigational Breakthrough Science

 

Compound Tumor Type Relevant
Pathway
Highest Phase of Development Location

Pexidartinib (PLX3397)

Tenosynovial Giant Cell Tumor (TGCT)* ENLIVEN

 FDA Breakthrough Designation
Orphan Drug Designation in US and EU

CSF-1R

Phase 3

US / EU

DS-1647

Glioblastoma SAKIGAKE Designation
Orphan Drug Designation in Japan

Oncolytic HSV-1

Phase 2

Japan

KTE-C19 (axicabtagene ciloleucel) Large B Cell Lymphoma CD19 CAR-T Phase 2 Japan
DS-1205 (in combination with osimertinib) Non-Small Cell Lung Cancer AXL Phase 1 preparation US
DS-1205 [in combination with gefitinib] Non-Small Cell Lung Cancer AXL Phase 1 preparation Japan
DS-1001 Gliomas IDH1 Phase 1 Japan
PLX2853 Solid Tumors BRD4 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-0301
08/18

 

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Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order to create meaningful treatments for patients with cancer.

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