(BPT) - Most men living with prostate cancer are familiar with their PSA, or prostate-specific antigen, level. Often, they have been getting PSA tests as part of regular health screenings since even before their diagnosis.¹

Now, there is another important biomarker to know about: PSMA, meaning prostate-specific membrane antigen. PSMA is a biomarker that is located on the outside of prostate cancer cells and found in more than 80% of men with prostate cancer. Both PSA and PSMA can help doctors diagnose and track the progression of prostate cancer.^2,3

Unlike PSA tests, doctors use PET (positron emission tomography) scans to test for PSMA. The PET scan works by using a tracer that attaches to PSMA and enables your doctor to detect precisely where PSMA-positive tumors reside in the body. Importantly, a PSMA scan can also provide valuable information for evaluating available treatment options with your doctor.^2,4

When prostate cancer advances and spreads to other parts of the body, and remains unresponsive to hormone treatment, it is called metastatic castration-resistant prostate cancer (mCRPC).⁵ PLUVICTO^® (lutetium Lu 177 vipivotide tetraxetan) is a type of precision medicine that targets PSMA-positive cancer cells. PLUVICTO attaches to PSMA and releases radiation treatment that can damage and kill PSMA-positive tumor cells.⁶

PLUVICTO is a radioligand therapy (RLT) and the first and only RLT approved for the treatment of adult patients with PSMA-positive mCRPC who have already been treated with other anticancer treatments (ie, androgen receptor pathway inhibition and taxane-based chemotherapy).⁶

To learn more about PLUVICTO, go to www.Pluvicto.com and see below for Important Safety Information.

What is PLUVICTO^® (lutetium Lu 177 vipivotide tetraxetan)?

PLUVICTO is a radiopharmaceutical used to treat adults with an advanced cancer called prostate-specific membrane antigen­-­positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that:

• has spread to other parts of the body (metastatic), and
• has already been treated with other anticancer treatments

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PLUVICTO?

Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with an increased risk for cancer.

To minimize radiation exposure to others following administration of PLUVICTO, limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days, refrain from sexual activity for 7 days, and sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days.

PLUVICTO may cause serious side effects, including:

• Low level of blood cell counts. Tell your doctor right away if you develop any new or worsening symptoms, including:
  • Tiredness or weakness
  • Pale skin
  • Shortness of breath
  • Bleeding or bruising more easily than normal or difficulty stopping bleeding
  • Frequent infections with signs such as fever, chills, sore throat, or mouth ulcers

• Kidney problems. Tell your doctor right away if you develop any new or worsening symptoms, including passing urine less often or passing much smaller amounts of urine than usual

Before you receive PLUVICTO, tell your doctor if any of these apply to you:

• You have low level of blood cell counts (hemoglobin, white blood cell count, absolute neutrophil count, platelet count)
• You have or have had tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty stopping bleeding, or frequent infections with signs such as fever, chills, sore throat, or mouth ulcers (possible signs of myelosuppression)
• You have or have had kidney problems
• You have or have had any other type of cancer or treatment for cancer, as PLUVICTO contributes to your long-term cumulative radiation exposure
• You are sexually active as:
  • All radiopharmaceuticals, including PLUVICTO, have the potential to cause harm to an unborn baby
  • You should use effective contraception for intercourse during treatment with PLUVICTO and for 14 weeks after your last dose
  • PLUVICTO may cause temporary or permanent infertility

Before administration of PLUVICTO, you should drink plenty of water in order to urinate as often as possible during the first hours after administration.

The most common side effects of PLUVICTO include:

• Tiredness
• Dry mouth
• Nausea
• Low red blood cell count
• Loss of appetite
• Changes in bowel movements (constipation or diarrhea)
• Vomiting
• Low blood platelet count
• Urinary tract infection
• Weight loss
• Abdominal pain

These are not all of the possible side effects of PLUVICTO. Call your doctor for advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

References:

1. National Cancer Institute. Prostate-specific antigen (PSA) test. Accessed July 25, 2023. https://www.cancer.gov/types/prostate/psa-fact-sheet
2. Hope TA, Aggarwal R, Chee B, et al. Impact of ⁶⁸Ga-PSMA-11 PET on management in patients with biochemically recurrent prostate cancer. J Nucl Med. 2017;58(12):1956-1961.
3. Sonni I, Eiber M, Fendler WP, et al. Impact of ⁶⁸Ga-PSMA-11 PET/CT on staging and management of prostate cancer patients in various clinical settings: a prospective single-center study. J Nucl Med. 2020;61:1153-1160. doi:10.2967/jnumed.119.237602
4. Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective randomised, multi-centre study. Lancet. 2020;395:1208-1216.
5. Society of Nuclear Medicine and Molecular Imaging. Radiopharmaceutical therapy and prostate cancer. Accessed July 24, 2023. https://www.snmmi.org/AboutSNMMI/Content.aspx?ItemNumber=12772
6. Pluvicto. Prescribing information. Advanced Accelerator Applications USA, Inc.