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New FDA approval renews hope for advanced prostate cancer patients

Posted at 12:52 PM, Apr 11, 2022
and last updated 2022-04-11 15:52:30-04

Novartis is a paid sponsor of The Morning Blend.

US Food and Drug Administration (FDA) has approved a new therapy, Pluvicto, for the treatment of adults with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (or PSMA-positive mCRPC). This type of prostate cancer has spread to other parts of the body (metastatic), and is progressing after treatment with other anticancer therapies1.

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is the first FDA-approved targeted radioligand therapy (RLT) and is an important clinical advancement for patients with prostate cancer1. Data shows it can significantly improve survival rates for those with progressing mCRPC who have been treated with other therapy options1. Pluvicto works by targeting cells with the PSMA receptor, which is a biomarker located on the outside of cells and is highly expressed in more than 80% of patients with prostate cancer, making it an important way to assess the progression of metastatic prostate cancer1,2-8.

Pluvicto contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer. Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Minimize radiation exposure during and after treatment with Pluvicto consistent with institutional good radiation safety practices and patient treatment procedures. Pluvicto is associated with other risks; please see the Important Safety Information at the end of this communication

Why this matters:
Prostate cancer is the second most common cancer in Americans with a prostate gland. The American Cancer Society’s estimates for prostate cancer in the US for 2021 are9:

1. About 248,530 new cases of prostate cancer

2. About 34,130 deaths from prostate cancer

10%-20% of patients with prostate cancer develop CRPC within 5 years of diagnosis and over 80% of these cases are metastatic at the time of CRPC diagnosis10. In CRPC, the tumor stops responding to hormonal therapies and in metastatic CRPC, the tumor spreads to other parts of the body, such as neighboring organs or bones10. Presently, patients with metastatic prostate cancer have a less than 3 in 10 chance of surviving for 5 years11.

FDA approval of Pluvicto is based on the Phase III VISION trial. Participants treated with Pluvicto plus SOC had a 38% reduction in risk of death; both alternate primary endpoints of overall survival and radiographic disease progression free survival were met1.

PLUVICTOTM (lutetium Lu 177 vipivotide tetraxetan) 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
Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with increased risk for cancer. To minimize radiation exposure to others following administration of PLUVICTO, patients are advised to limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days, to refrain from sexual activity for 7 days, and to 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 low level of blood cell counts. Patients should tell their doctor right away if they develop any new or worsening symptoms, including tiredness or weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding, or frequent infections with signs such as fever, chills, sore throat, or mouth ulcers. PLUVICTO may also cause problems with kidneys. Patients should tell their doctor right away if they develop any new or worsening symptoms, including passing urine less often or passing much smaller amounts of urine than usual.

Before receiving PLUVICTO, patients should tell their doctor if they have low level of blood cell counts (hemoglobin, white blood cell count, absolute neutrophil count, platelet count); if they 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); if they have or have had kidney problems; if they have or have had any other type of cancer or treatment for cancer, as PLUVICTO contributes to long-term cumulative radiation exposure; and if they are sexually active, as all radiopharmaceuticals, including PLUVICTO, have the potential to cause harm to an unborn baby. Patients should use effective contraception for intercourse during treatment with PLUVICTO and for 14 weeks after the last dose. PLUVICTO may cause temporary or permanent infertility.

Before administration of PLUVICTO patients 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, and abdominal pain.

Please see full Prescribing Information for PLUVICTO, available at https://www.novartis.us/sites/www.novartis.us/files/pluvicto.pdf [novartis.us]

References:

1. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2022.

2. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol 2018;8:623.

3. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane antigen expression in prostatic intraepithelial neoplasia and adenocarcinoma: a study of 184 cases. Cancer 1998;82(11):2256–61

4. Pomykala KL, Czernin J, Grogan TR, et al. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. J Nucl Med 2020;61(3):405–11

5. Sant GR, Knopf KB, Albala DM. Live-single-cell phenotypic cancer biomarkers-future role in precision oncology? NPJ Precision Oncology 2017;1(1):21

6. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is associated with early PSA recurrence in surgically treated prostate cancer. Prostate 2011;71(3):281–8

7. 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):1956–61

8. Hofman MS, Violet J, Hicks RJ et al. [177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2.

9. American Cancer Society. Key Statistics for Prostate Cancer; Cancer A-Z, Prostate Cancer, About Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html [cancer.org]. Accessed January 5, 2022.

10. Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract 2011;65(11):1180–92

11. National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Program. https://seer.cancer.gov/statfacts/html/prost.html [seer.cancer.gov]. Accessed August 2021.