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Pluvicto (Lutetium (177Lu) vipivotide tetraxetan)
Australian Prescription Medicine Decision Summary
Published
Product name
Pluvicto
Active ingredient
Lutetium (177Lu) vipivotide tetraxetan
Submission type
Type A - New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Pluvicto (Lutetium (177Lu) vipivotide tetraxetan) has been approved for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
How this medicine works
The active ingredient in Pluvicto is the radionuclide lutetium-177 (a radionuclide is a chemical that has an unstable atomic nucleus and as a result emits radiation). The radionuclide is linked to a molecule that targets it to PSMA, a protein that is highly expressed on prostate cancer cells, including metastatic castration-resistant prostate cancer cells. Upon binding of Pluvicto to PSMA-expressing cancer cells, lutetium-177 delivers therapeutic radiation to the targeted cell, as well as to surrounding cells, and induces DNA damage which can lead to the death of the cancer cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The registration of Pluvicto in mCRPC is primarily based on the efficacy demonstrated in patients with progressive, prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC) established in the VISION trial, a randomised, multicenter, open-label Phase III study. 831 patients were randomised to receive either Pluvicto every 6 weeks for up to a total of 6 doses plus best standard of care (BSoC) or BSoC alone. Treatment with Pluvicto plus BSoC demonstrated a statistically significant improvement in overall survival and radiographic progression-free survival compared to treatment with BSoC alone.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.