Frequently Asked Questions

• PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT)

  • For patients with PSMA-positive (PSMA+) metastatic castration-resistant prostate cancer (mCRPC) who have received an androgen receptor pathway inhibitor (ARPI) and are considered appropriate to delay taxane-based chemotherapy¹

  • For patients with PSMA+ mCRPC who have received an ARPI and taxane-based chemotherapy¹

• A radioligand is a 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 it^2,3

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)¹

• 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 death^1,4-7

Click here for more on how PLUVICTO works.

• Yes, PLUVICTO is approved for PSMA+ mCRPC patients previously treated with an ARPI¹

  • 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)¹

  • 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])^8,*

  • 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 ARPI¹

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.⁸

• 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 chemotherapy^1,*

*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 chemotherapy¹

• Yes, 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 ADT¹

• In the PSMAfore trial, the most common adverse reactions (≥20%) for patients with PSMA+ mCRPC after 1 ARPI were dry mouth, fatigue, nausea, constipation, decreased appetite, and arthralgia¹

• 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 persist^1,9

• PLUVICTO 7.4 gigabecquerel (GBq) (200 millicurie) is administered intravenously once every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Pre-filled syringe injections last less than ~10 minutes and are followed by a saline flush¹