Frequently Asked Questions
About PLUVICTO
mAPM-naive or -sensitive prostate cancer (mAPMN/S PC) is metastatic prostate cancer that is naive to or remains sensitive to androgen pathway modulation. The term stands for metastatic androgen pathway modulation-naive or -sensitive prostate cancer and reflects terminology introduced by Prostate Cancer Working Group 4 (PCWG4)1,*
This disease state may also be referred to as:
Metastatic hormone-sensitive prostate cancer, or mHSPC1
Metastatic castration-sensitive prostate cancer, or mCSPC1
*PCWG4 updated prostate cancer terminology to describe disease states and prior therapies in a more patient-centered way, with a focus on androgen pathway modulation.1
mAPM-resistant prostate cancer (mAPMR PC) is metastatic prostate cancer that has become resistant to androgen pathway modulation. The term stands for metastatic androgen pathway modulation-resistant prostate cancer and reflects terminology introduced by Prostate Cancer Working Group 4 (PCWG4)1,*
This disease state may also be referred to as:
Metastatic castration-resistant prostate cancer, or mCRPC1
*PCWG4 updated prostate cancer terminology to describe disease states and prior therapies in a more patient-centered way, with a focus on androgen pathway modulation.1
PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT)2
For patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) in combination with ARPI2
For patients with PSMA+ metastatic castration-resistant prostate cancer (mCRPC) who have received an ARPI and are considered appropriate to delay taxane-based chemotherapy2
For patients with PSMA+ mCRPC who have received an ARPI and taxane-based chemotherapy2
A radioligand is a cancer treatment that couples a therapeutic radioactive isotope with a specific cell-targeting molecule—the ligand. When a ligand binds to the cancer cell, its radioactivity is released in the cancer cell to selectively destroy it and the cells around it3,4
Click here to learn how RLTs are an emerging pillar of oncology care. ↗
PLUVICTO works by targeting PSMA+ cells regardless of where they have metastasized (bone, nodal, or visceral)2
PLUVICTO is comprised of 2 key components: Lutetium-177, a cytotoxic radionuclide, and PSMA-617, a PSMA-targeting ligand. Lutetium-177, the cytotoxic radionuclide of PLUVICTO, emits DNA-breaking radiation within the cell. The short path length of the radiation emitted by PLUVICTO, approximately 2 millimeters maximum, causes single- and double-stranded DNA breaks in targeted cells as well as surrounding cells, which can lead to cell death2,5-7
Who can take PLUVICTO
Yes, PLUVICTO is FDA approved for patients with mHSPC in combination with ARPI
PLUVICTO offers the chance to live longer without progression. In mHSPC (PSMAddition), final analysis: PLUVICTO + androgen receptor pathway inhibitor (ARPI) reduced the risk of radiographic progression or death by 33% vs ARPI (HR=0.67 [95% CI, 0.55-0.82])2,8,*
In mHSPC (PSMAddition), primary analysis: PLUVICTO + ARPI reduced the risk of radiographic progression or death by 28% vs ARPI (HR=0.72 [95% CI, 0.58-0.90]; P=0.002)2,†
The PSMAddition clinical trial was the first positive trial vs ADT + ARPI in the majority of patients with PSMA+ mHSPC. The trial measured rPFS among 1144 patients with PSMA+ mHSPC. They were divided into 2 groups: 572 patients were treated with PLUVICTO + ARPI. PLUVICTO was given once every 6 weeks for up to 6 treatments. 572 patients were treated with only ARPI2
See PLUVICTO efficacy results here.
*Median rPFS was not reached in the PLUVICTO + ARPI arm vs 48.5 months (95% CI, 40.5-NE) in the ARPI arm. Final rPFS analysis was performed with a median follow-up period of 37.7 months vs the primary analysis at 23.6 months. This analysis was not controlled for Type-I error.2,8,9
†Median rPFS was not reached in either arm.2
Yes, PLUVICTO is approved for PSMA+ mCRPC patients previously treated with an ARPI2
In the PSMAfore trial after only 1 ARPI, PLUVICTO achieved statistically significant radiographic progression-free survival (rPFS). Primary analysis: Median rPFS was 9.3 months with PLUVICTO vs 5.6 months with a change in ARPI (HR=0.41 [95% CI, 0.29-0.56]; P<0.0001)2
In the updated exploratory analysis, PLUVICTO more than doubled median rPFS vs a change in ARPI. Median rPFS was 11.6 months with PLUVICTO vs 5.6 months with a change in ARPI (HR=0.49 [95% CI, 0.39-0.61])10,*
The PSMAfore clinical trial measured rPFS and included 468 patients with PSMA+ mCRPC: 234 patients received PLUVICTO (once every 6 weeks for up to 6 treatments), and 234 patients received a change in ARPI2
See PLUVICTO efficacy results here.
*Exploratory rPFS analysis was performed with a median follow-up period of 24 months vs the primary analysis at 7 months. This analysis was not controlled for Type-1 error.10
Efficacy & Safety
PLUVICTO is a PSMA-targeted radioligand therapy that delivers radiation directly to PSMA-positive cancer cells and surrounding cells. It is an approved alternative for patients with PSMA+ mCRPC who have been treated with an ARPI and are considered appropriate to delay taxane-based chemotherapy2,*
*No direct head-to-head trials vs taxanes have been conducted; treatment choice should be based on individual patient factors, including PSMA-PET imaging results, performance status, and tolerability profiles.
Yes, for appropriate patients. PLUVICTO is indicated after only 1 ARPI in patients with PSMA+ mCRPC who are considered appropriate to delay taxane-based chemotherapy2
In patients with mHSPC, PLUVICTO must be used in combination with ADT. In the PSMAddition trial, patients received a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or had a bilateral orchiectomy2
In patients with mCRPC, PLUVICTO can be used in combination with ADT. Supportive care that was administered at the investigator's discretion in the PSMAfore and VISION trials included ADT2
Most common adverse reactions (≥20%) are2:
In the PSMAddition trial, for patients with PSMA+ mHSPC: Fatigue, dry mouth, and nausea
In the PSMAfore trial, for patients with PSMA+ mCRPC after 1 ARPI: Dry mouth, fatigue, nausea, constipation, decreased appetite, and arthralgia
When using PLUVICTO, always adhere to the ALARA (as low as reasonably achievable) guiding principle of radiation safety and precaution. Safety measures include proper, slow intravenous administration and monitoring of adverse events which may require temporary dose interruption and reduction, or permanent discontinuation of treatment if adverse reactions persist2,11
Dosing & Administration
PLUVICTO 7.4 gigabecquerels (GBq) (200 millicuries) is administered intravenously once every 6 weeks for 6 doses. Pre-filled syringe injections last less than ~10 minutes and are followed by a saline flush2
Patient Access
Use the PLUVICTO Treatment Center Locator* here to find sites in your local area, then connect with your selected treatment center to understand the referral requirements.
*There are over 800 PLUVICTO treatment sites in the United States. Please note that the PLUVICTO Treatment Centers listed are only those that have authorized their participation on the PLUVICTO website.12
Once you have confirmed your patient with PSMA+ mCRPC or PSMA+ mHSPC is eligible, see how to prescribe PLUVICTO in your electronic health record (EHR) system here.
Your patients with mHSPC are eligible for PLUVICTO (in combination with ARPI) if they have received2:
An mHSPC diagnosis
Imaging confirming PSMA+ disease
mCRPC after 1 ARPI: Your patients are eligible for PLUVICTO if they have received2:
An mCRPC diagnosis
Imaging confirming PSMA+ disease
1 ARPI at any point in their prostate cancer journey