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Pluvicto based on Lutetium ( 177Lu ) vipivotide tetraxetan as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer. European Commission approved


The European Commission ( EC ) has approved Pluvicto [ Lutetium ( 177Lu ) vipivotide tetraxetan ], a targeted radioligand therapy.
Pluvicto is approved in combination with androgen deprivation therapy ( ADT ) with or without androgen receptor ( AR ) pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen ( PSMA )–positive metastatic castration-resistant prostate cancer ( mCRPC ). These patients have been treated with AR pathway inhibition and taxane-based chemotherapy.

The EC approval was granted based on results from the pivotal phase III VISION trial, where participants, previously treated with AR pathway inhibition and taxane based chemotherapy, receiving Pluvicto plus best standard of care ( BSoC ) had a 38% reduction in the risk of death and a statistically significant reduction ( 60% ) in the risk of radiographic disease progression or death ( rPFS ) compared to best standard of care alone.
About a third ( 30% ) of patients with evaluable disease at baseline has demonstrated an objective response ( per RECIST 1.1 ) with Pluvicto plus best standard of care, compared to the 2% in the BSoC-alone arm.

Pluvicto is an intravenous radioligand therapy combining a targeting compound ( a ligand ) with a therapeutic radionuclide ( a radioactive particle, in this case Lutetium-177 ).
After administration into the bloodstream, Pluvicto binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death.

VISION is an international, prospective, randomized, open-label, multicenter, phase III study that assessed the efficacy and safety of Lutetium ( 177Lu ) vipivotide tetraxetan ( 7.4 GBq administered by IV infusion every 6 weeks for a maximum of 6 cycles ) plus investigator-chosen standard of care ( BSoC ) in the investigational arm, versus BSoC in the control arm.
Patients with PSMA PET-scan positive metastatic castration-resistant prostate cancer who have received androgen receptor pathway inhibition and taxane-based chemotherapy, were randomized in a 2:1 ratio in favor of the investigational arm.
The alternate primary endpoints were radiographic progression-free survival and overall survival.
The study enrolled 831 patients.

Approximately 473,300 prostate cancer cases and 108,000 prostate cancer-related deaths occurred across Europe in 2020.
Patients with metastatic prostate cancer have an approximate 3 in 10 chances of surviving 5 years. ( Xagena )

Source: Novartis, 2022

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