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    • Development Update
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    FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer

    Details:

    Tivdak (tisotumab vedotin) is an antibody-drug conjugate that acts as coagulation factor III binding agent & tubulin inhibitor. It is approved for the treatment of recurrent or metastatic cervical cancer.


    Lead Product(s): Tisotumab Vedotin

    Therapeutic Area: Oncology Product Name: Tivdak

    Highest Development Status: ApprovedProduct Type: Large molecule

    Recipient: Pfizer Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 29, 2024

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    Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

    Details:

    Through the Acquisition, Genmab will leverage the worldwide rights of three candidates in clinical development, including PRO1184 (rinatabart sesutecan) for the treatment of FRα-expressing platinum-resistant ovarian cancer.


    Lead Product(s): Rinatabart Sesutecan

    Therapeutic Area: Oncology Product Name: PRO1184

    Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

    Recipient: ProfoundBio

    Deal Size: $1,800.0 million Upfront Cash: $1,800.0 million

    Deal Type: Acquisition April 03, 2024

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    U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refra...

    Details:

    Epkinly (epcoritamab) is an IgG1-bispecific antibody, being evaluated to-treat relapsed/refractory follicular lymphoma, which is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types.


    Lead Product(s): Epcoritamab

    Therapeutic Area: Oncology Product Name: Epkinly

    Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: AbbVie Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 26, 2024

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    Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer

    Details:

    Tivdak (tisotumab vedotin-tftv) is a tissue factor (TF)-directed antibody drug conjugate. It is approved by USFDA for the treatment of cervical cancer.


    Lead Product(s): Tisotumab Vedotin

    Therapeutic Area: Oncology Product Name: Tivdak

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Pfizer Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 02, 2024

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    TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patie...

    Details:

    Tivdak (tisotumab vedotin-tftv) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology. It is being evaluated in phase 3 studies for the treatment of recurrent or metastatic cervical cancer.


    Lead Product(s): Tisotumab Vedotin

    Therapeutic Area: Oncology Product Name: Tivdak

    Highest Development Status: Phase IIIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Pfizer Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 09, 2024

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    Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma

    Details:

    Epkinly (epcoritamab) is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. It is under clinical development for the treatment of relapsed/refractory follicular lymphoma.


    Lead Product(s): Epcoritamab-bysp

    Therapeutic Area: Oncology Product Name: Epkinly

    Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

    Partner/Sponsor/Collaborator: AbbVie Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 27, 2023

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    TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemot...

    Details:

    Tivdak (tisotumab vedotin) is an antibody-drug conjugate, which is investigating in phase III and met its primary endpoint of overall survival for recurrent or metastatic cervical cancer compared to chemotherapy.


    Lead Product(s): Tisotumab Vedotin

    Therapeutic Area: Oncology Product Name: Tivdak

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Seagen

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 22, 2023

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    Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DL...

    Details:

    Tepkinly (epcoritamab) is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology, which is received approval from EU for Diffuse Large B-cell Lymphoma.


    Lead Product(s): Epcoritamab-bysp

    Therapeutic Area: Oncology Product Name: Tepkinly

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: AbbVie Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 25, 2023

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    EPKINLYTM (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain ...

    Details:

    Epkinlytm (epcoritamab) is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology, which is received approval from EU for Diffuse Large B-cell Lymphoma.


    Lead Product(s): Epcoritamab-bysp

    Therapeutic Area: Oncology Product Name: Epkinlytm

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: AbbVie Inc

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 25, 2023

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    Genmab and Seagen Announce that TIVDAK® (tisotumab vedotin-tftv) Met its Primary Endpoint of Improved Overall Survival in Patients with Recurrent or Me...

    Details:

    TIVDAK (tisotumab vedotin) is an antibody-drug conjugate, which is investigating in phase III and met its primary endpoint of overall survival for recurrent or metastatic cervical cancer compared to chemotherapy.


    Lead Product(s): Tisotumab Vedotin

    Therapeutic Area: Oncology Product Name: Tivdak

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Seagen

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 04, 2023

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