Pluvicto - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
lutetium (177Lu) vipivotide tetraxetan
Post-authorisationHuman
Pluvicto is a medicine used to treat adults with progressive PSMA-positive mCRPC. It is used together with androgen deprivation therapy (treatment to lower male sex hormones) in adults previously treated with androgen receptor pathway inhibitors (medicines for prostate cancer), and a medicine of the group of cancer medicines known as taxanes. Androgen receptor pathway inhibitors may also be added to Pluvicto and androgen deprivation therapy.
Pluvicto has been authorised in the EU since December 2022.
It contains the active substance lutetium (177Lu) vipivotide tetraxetan and is given by injection or infusion (drip) into a vein once every 6 weeks for up to 6 doses.
Further information on Pluvicto’s current uses can be found on Pluvicto's medicine page.
The company applied to extend the use of Pluvicto to treat adults with PSMA-positive mCRPC who have no or mild symptoms, after their cancer has worsened despite treatment with a hormone‑blocking medicine. It was intended for patients who are not yet eligible for chemotherapy.
Pluvicto works by attaching to the PSMA protein found on the surface of the prostate cancer cells. The radioactivity it emits kills the cancer cells it is attached to but has little effect on neighbouring cells.
The company submitted data from a study in adults with PSMA-positive, progressive, mCRPC who were previously treated with a hormone‑blocking medicine and who were not yet eligible for taxane-based chemotherapy. Pluvicto was compared with a different hormone-blocking medicine. The main measure of effectiveness was how long people lived without the cancer showing signs of worsening on imaging tests (radiographic progression-free survival). The study also looked at how long people lived (overall survival).
The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.
Based on the review of the information and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Pluvicto could not have been authorised for use in adults with PSMA‑positive mCRPC who have no or mild symptoms and whose disease has progressed despite treatment with a hormone‑blocking medicine.
Although the main study showed that the medicine could increase the time before the cancer grew or spread compared with a hormone-blocking treatment, it was not clear whether this delay provides a meaningful benefit for patients. This is because the comparator treatment, a hormone-blocking treatment, was not considered to be adequate for people with this stage of prostate cancer. In addition, treatment with Pluvicto had no impact on how long people lived overall, compared with a hormone-blocking treatment.
Therefore, at the time of the withdrawal, the Agency’s opinion was that the company had not provided enough information to support the application for a change to the marketing authorisation of Pluvicto.
In its letter notifying the Agency of the withdrawal of application, the company stated it withdrew based on the fact that feedback from the CHMP indicated that the Committee would not be able to conclude, on the basis of the data provided, that the benefits of the medicine outweigh its risks in the applied indication.
The company informed the Agency that there are no consequences for patients in clinical trials using Pluvicto.
If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Pluvicto continues to be authorised in adults with progressive, PSMA-positive mCRPC.