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Find Clinical Drug Pipeline Developments & Deals for Lutetium-177 Vipivotide Tetraxetan
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.
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).
Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177).
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).
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.
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.
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.
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.
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.
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.