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Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen, which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan,68Ga-PSMA-11
Therapeutic Area: Oncology Product Name: Pluvicto
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2024
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen (PSMA) which is approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Pluvicto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2024
Details:
Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
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 December 13, 2022
Details:
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
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 December 05, 2022
Details:
The positive CHMP opinion is based on Phase III VISION study, in which Pluvicto plus BSoC demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.
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 October 14, 2022
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
Details:
As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Pluvicto
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 29, 2022
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
Partner/Sponsor/Collaborator: Advanced Accelerator Applications
Deal Size: $172.0 million Upfront Cash: $12.0 million
Deal Type: Agreement March 29, 2022
Details:
ITM to supply Advanced Accelerator Applications on an industrial scale with its high-quality n.c.a. lutetium-177 as core component of newly approved radiotherapeutic, Pluvicto for treatment of adult patients with prostate-specific membrane antigen and positive mCRPC.
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 March 25, 2022
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
Partner/Sponsor/Collaborator: Advanced Accelerator Applications
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2022
Details:
Pluvicto is the first FDA-approved targeted radioligand therapy for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). Pluvicto is expected to be available to physicians and patients within weeks.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Pluvicto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2022
Details:
New quality of life data for 177Lu-PSMA-617 plus standard of care shows delay in worsening of health-related quality of life and pain in heavily pre-treated patients with PSMA-positive metastatic castration-resistant prostate cancer compared to standard of care alone.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2021
Details:
This result validates the survival benefit of the same combination seen in a recently completed Phase I/II trial of Veyonda in men with end-stage metastatic castrate-resistant prostate cancer (mCRPC).
Lead Product(s): Idronoxil,Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Veyonda
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2021
Details:
The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival, which are key measures of clinical benefit in the mCRPC population.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
Details:
Phase III VISION study with 177Lu-PSMA-617 met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer.
Lead Product(s): Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
The study revealed that in late-stage prostate cancer patients who have exhausted all standard treatment options, a combination of 177Lu-PSMA-617 and Veyonda® is both safe and delivered promising efficacy outcomes, among them a median overall survival of 17.1 months.
Lead Product(s): Idronoxil,Lutetium-177 Vipivotide Tetraxetan
Therapeutic Area: Oncology Product Name: Veyonda
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
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
Partner/Sponsor/Collaborator: Advanced Accelerator Applications
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 02, 2020
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