Also known as: Lu-177 PSMA-617
Lutetium Lu 177 vipivotide tetraxetan is a PSMA-targeted radioligand therapy marketed as Pluvicto for metastatic castration-resistant prostate cancer. It is used in PSMA-positive disease settings after androgen receptor pathway inhibitor therapy and in specific pre/post-taxane contexts. The FDA first approved this product in March 2022, with later expansion for earlier use.
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
Radiopharmaceuticals are emerging as a promising therapeutic class in oncology, with theranostic approaches combining diagnostics and treatment gaining particular attention. Major pharmaceutical companies have invested billions in acquisitions while venture financing reached record levels.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07219147 |
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07200830 |
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial |
NOT_YET_RECRUITING | PHASE3 |
| NCT07150715 |
Alpha-Emitting Radionuclide or Beta-Emitting Radionuclide With Metastasis-Directed Stereotactic Body Radiotherapy for the Treatment of Recurrent, Oligometastatic Prostate Adenocarcinoma |
RECRUITING | PHASE2 |
| NCT06632977 |
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial |
RECRUITING | PHASE2 |
| NCT06526299 |
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease |
RECRUITING | PHASE2 |
| NCT06288113 |
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial |
RECRUITING | PHASE2 |
| NCT06216249 |
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) |
RECRUITING | PHASE2 |
| NCT06200103 |
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer |
RECRUITING | PHASE2 |
| NCT06145633 |
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer |
RECRUITING | PHASE2 |
| NCT05682443 |
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
