After clinical trial results demonstrated a four-month improvement in overall survival compared to best standard care, in March 2022 the U.S. Food and Drug Administration approved lutetium lu 177 vipivotide tetraxetan (PluvictoTM) to treat prostate-specific membrane antigen (PSMA)–expressing metastatic castration-resistant prostate cancer (mCRPC).
Mechanism of Action
Upon binding to PSMA-expressing cells, the beta-minus emission from lutetium lu 177 delivers radiation to PSMA-expressing and surrounding cells, inducing DNA damage that can lead to cell death.
Treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy
7.4 GBq (200 mCi) every six weeks for up to a total of six doses or until patients experience disease progression or unacceptable toxicities
Give as an IV injection using a disposable syringe fitted with a syringe shield (with or without a syringe pump), as an infusion using the gravity method (with or without an infusion pump), or as an infusion using the vial (with a peristaltic infusion pump)
In the radiopharmaceutical’s clinical trials, more than 20% of patients reported experiencing fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory values that decreased from baseline in more than 30% of patients were lymphocytes, hemoglobin, leukocytes, platelets, calcium, and sodium.
The agent must be used only by or under the control of healthcare providers who have specific training and experience in the safe use and handling of radiopharmaceuticals and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. Monitor patients for myelosuppression and renal toxicity.
Limit close contact (less than 3 feet) with household members for two days and with children or pregnant individuals for seven days. Refrain from sexual activity for seven days. Sleep in a separate bedroom from others for three days, from children for seven days, or from pregnant individuals for 15 days. Increase oral fluid intake and void as often as possible to reduce bladder radiation. Because the agent can cause fetal harm, male patients with female partners of reproductive potential must use effective contraception. The treatment may cause temporary or permanent infertility.
Special Populations Considerations
No significant differences in safety or efficacy were observed between patients aged 65 or older and younger patients in clinical trials.
Follow specific safety measures to minimize radiation exposure. Radiopharmaceuticals should be used only by or under the control of healthcare providers who are qualified through specific training and experience in their safe use and handling.