Clinical application and drug description of PLUVICTO (lutetium [177Lu] tersivirpitide) in the treatment of metastatic castration-resistant prostate cancer

PLUVICTO(lutetium[177Lu]tersivirpitide, trade name: Pluvicto) is a targeted radioligand therapy drug for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The drug was developed by Novartis and has been approved by the U.S. FDA and is available in many countries and regions. In China, PLUVICTO has not yet been approved for marketing, and patients need to obtain it through international channels.

Drug name and ingredients

Common name: Lutetium[177Lu]Lutetium Lu 177 vipivotide tetraxetan

Product name:Pluvicto

Molecular structure: It is composed of the radioactive isotope lutetium-177 and tersivirpitide (PSMA-617).

Indications and mechanism of action

PLUVICTOis indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). PSMA is a protein highly expressed on the surface of prostate cancer cells, PLUVICTO targets PSMA through tersivirpitide, The radioactive isotope Lutetium-177 is delivered directly to cancer cells, releasing β particle radiation, causing DNA damage, thereby inducing cancer cell death.

Dosing schedule and dosage

Recommended dose: intravenous injection once every 6 weeks, a single dose is 7.4GBq (200mCi), which can treat up to 6 cycles.

Administration: intravenous injection.

Preliminary preparation: It is recommended that patients perform PSMA before treatmentImaging to confirm tumor cell expression of PSMA.

Adverse reactions and precautions

Common adverse reactions:

≥20%Incidence: fatigue, dry mouth, nausea, anemia, loss of appetite, constipation.

≥30%Laboratory abnormalities: lymphopenia, hemoglobin decrease, leukopenia, thrombocytopenia, calcium decrease, and sodium decrease.

Warnings and Notes:

Radiation Exposure: During and after treatment, radiation exposure should be minimized and patients are advised to increase fluid intake and urinate as often as possible to reduce bladder radiation.

Myelosuppression: A complete blood count should be performed before treatment. When symptoms of myelosuppression occur, the dose should be adjusted or the drug should be discontinued according to the severity.

Nephrotoxicity: Advise patients to stay adequately hydrated and urinate frequently, and undergo laboratory testing of renal function.

Embryo-Fetal Toxicity: May cause harm to the fetus. It is recommended that male patients with female partners of reproductive potential use effective contraceptive measures.

Infertility: May cause temporary or permanent infertility.

Drug specifications and storage

Specification:1000MBq/mL (27mCi/mL) solution for intravenous injection.

Packaging: 30mLsingle dose vial in lead shielded container.

Storage Conditions: Store below30°C, avoid freezing, and store in original packaging to protect against ionizing radiation.

Shelf life:120 hours (5 days).

Clinical research and efficacy

In theVISION study,PLUVICTO in combination with standard therapy significantly extended overall survival and radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer. Specific results showed that the median overall survival time in the combination treatment group was 15.3 months, while that in the standard treatment group was 11.3 months; the median radiographic progression-free survival was 8.7 months compared with 3.4 months in the standard treatment group. Additionally, the overall response rate was 29.8% in the combination therapy group and 1.7% in the standard-therapy group.

Acquisition methods and fees

In China,PLUVICTO has not been approved for marketing. Patients can obtain it through international channels, but be aware that higher costs and complex import procedures may be involved. Specific costs vary by region and channel, and patients are advised to consult professional medical institutions or drug suppliers before considering use.

PLUVICTO, as a targeted radioligand therapy, provides a new treatment option for patients with metastatic castration-resistant prostate cancer. Although it has not yet been launched in China, its clinical application and research results internationally provide more hope for patients. In the future, with the advancement of relevant approval procedures, PLUVICTO is expected to be launched in the Chinese market, benefiting more patients.

Reference materials:https://www.novartis.com/us-en/sites/novartis_us/files/pluvicto.pdf