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    MHRA Grants Marketing Authorisation for Novartis’ Radioligand Therapy Pluvicto® (Lutetium (¹⁷⁷lu) Vipivotide Tetraxetan) in Advanced Prostate Ca...

    Details:

    Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) is indicated for the treatment of adult patients with PSMA-positive mCRPC who have been treated with AR pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.


    Lead Product(s): Lutetium-177 Vipivotide Tetraxetan

    Therapeutic Area: Oncology Product Name: Pluvicto

    Highest Development Status: ApprovedProduct Type: Large molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 11, 2022

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    Otsuka Subsidiary to Receive Payment and Royalties from Approval in U.S. of - Out-licensed by ABX in Germany, an indirectly-owned subsidiary of Otsuka P...

    Details:

    Advanced Accelerator Applications (AAA) and Endocyte, Inc., both Novartis companies, successfully completed full-scale development of Pluvicto and also received Breakthrough Therapy designation from the U.S. FDA last year.


    Lead Product(s): Lutetium-177 Vipivotide Tetraxetan

    Therapeutic Area: Oncology Product Name: Pluvicto

    Highest Development Status: ApprovedProduct Type: Large molecule

    Recipient: ABX Advanced Biochemical Compounds

    Deal Size: $172.0 million Upfront Cash: $12.0 million

    Deal Type: Agreement March 29, 2022

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    Novartis Pluvicto™ Approved by FDA as First Targeted Radioligand Therapy for Treatment of Progressive, PSMA-positive Metastatic Castration-Resistant P...

    Details:

    FDA approval was based on VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of OS and radiographic PFS were met.


    Lead Product(s): Lutetium-177 Vipivotide Tetraxetan

    Therapeutic Area: Oncology Product Name: Pluvicto

    Highest Development Status: ApprovedProduct Type: Large molecule

    Recipient: Novartis Pharmaceuticals Corporation

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 23, 2022

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    ITM expands PSMA-617 supply agreement for no-carrier-added Lutetium-177

    Details:

    ITM will provide Endocyte with supply of n.c.a 177Lu for its investigational 177Lu-PSMA-617 radioligand therapy for patients with metastatic castration-resistant prostate cancer.


    Lead Product(s): Lutetium-177 Vipivotide Tetraxetan

    Therapeutic Area: Oncology Product Name: Undisclosed

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Recipient: ITM

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 02, 2020

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