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Chemistry

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Also known as: Trastuzumab dm1 , trastuzumab mcc dm1 , trastuzumab mcc dm1 antibody drug conjugate , trastuzumab mcc dm1 immunoconjugate
Trastuzumab emtansine is a recombinant IgG1 kappa, humanized monoclonal antibody, andbiosimilar to Herceptin.

Drugs in Development

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Details:

Kadcyla (trastuzumab emtansine) is a HER2 modulator, antibody-drug conjugate. It is being evaluated in phase 3 clinical trials for the treatment of HER2-positive early-stage breast cancer.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Kadcyla

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 08, 2023

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01

F. Hoffmann-La Roche

Switzerland
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Duphat
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

Details : Kadcyla (trastuzumab emtansine) is a HER2 modulator, antibody-drug conjugate. It is being evaluated in phase 3 clinical trials for the treatment of HER2-positive early-stage breast cancer.

Brand Name : Kadcyla

Molecule Type : Large molecule

Upfront Cash : Not Applicable

December 08, 2023

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Details:

TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.


Lead Product(s): Tucatinib,Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Tukysa

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2023

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Seagen

U.S.A
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Duphat
Not Confirmed

Seagen

U.S.A
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Duphat
Not Confirmed

Details : TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.

Brand Name : Tukysa

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 06, 2023

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Details:

Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Ujvira

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 24, 2021

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Duphat
Not Confirmed
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Not Confirmed

Details : Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need.

Brand Name : Ujvira

Molecule Type : Large molecule

Upfront Cash : Not Applicable

May 24, 2021

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Details:

Approval is based on the study which evaluated the efficacy and safety of Kadcyla adjuvant therapy in patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin.


Lead Product(s): Trastuzumab Emtansine

Therapeutic Area: Oncology Brand Name: Kadcyla

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2020

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Duphat
Not Confirmed
Duphat
Not Confirmed

Details : Approval is based on the study which evaluated the efficacy and safety of Kadcyla adjuvant therapy in patients with HER2-positive early breast cancer who did not have pathologic complete response following neoadjuvant therapy including Herceptin.

Brand Name : Kadcyla

Molecule Type : Large molecule

Upfront Cash : Not Applicable

August 21, 2020

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FDF Dossiers

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01

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 100MG/VIAL

Packaging : 15ML/20ML

Approval Date :

Application Number : 2412365

Regulatory Info :

Registration Country : Canada

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F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
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Duphat
Not Confirmed

TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 160MG/VIAL

Packaging :

Approval Date :

Application Number : 2473224

Regulatory Info :

Registration Country : Canada

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F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
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F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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09

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

F. Hoffmann-La Roche

Switzerland
Duphat
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Europe

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01

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansin

Brand Name : Kadcyla

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 160 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Canada

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01

Duphat
Not Confirmed
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Duphat
Not Confirmed

TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 100MG/VIAL

Packaging : 15ML/20ML

Approval Date :

Application Number : 2412365

Regulatory Info :

Registration Country : Canada

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02

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 160MG/VIAL

Packaging :

Approval Date :

Application Number : 2473224

Regulatory Info :

Registration Country : Canada

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Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Australia

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01

Duphat
Not Confirmed
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arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Duphat
Not Confirmed
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arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Duphat
Not Confirmed
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arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Duphat
Not Confirmed
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Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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07

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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08

Duphat
Not Confirmed
arrow
arrow
Duphat
Not Confirmed

trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank
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South Africa

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Duphat
Not Confirmed
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Trastuzumab Emtansine

Brand Name : Kadcyla 100

Dosage Form : INF

Dosage Strength : 100mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Duphat
Not Confirmed
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Trastuzumab Emtansine

Brand Name : Kadcyla 160

Dosage Form : INF

Dosage Strength : 160mg

Packaging : 8X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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