Truqap - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn
capivasertib
Post-authorisationHuman
Truqap is a cancer medicine used in adults to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body) when the cancer has come back or worsened after hormonal treatment.
It is used when the cancer cells have receptors (targets) for certain hormones on their surface (ER-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
The breast cancer cells must also have been shown to have one or more mutations (changes) in the PIK3CA, AKT1 or PTEN genes. Truqap is used in combination with fulvestrant (an anti-oestrogen medicine).
Truqap has been authorised in the EU since June 2024.
It contains the active substance capivasertib and is available as tablets.
The company applied for an extension of indication to add the treatment of newly diagnosed PTEN-deficient prostate cancer that responds to hormone treatment and is metastatic. It was to be used in combination with abiraterone, prednisolone or prednisone, as well as background hormonal therapy.
The active substance in Truqap, capivasertib, blocks the activity of enzymes (proteins) known as serine/threonine kinase (AKT) 1, 2 and 3. These enzymes play an important role in the growth and division of cancer cells that have mutations in the PIK3CA, AKT1 or PTEN genes. By blocking AKT1, AKT2 and AKT3, Truqap reduces the growth of cancer cells. In newly diagnosed PTEN-deficient, metastatic prostate cancer, Truqap was expected to work in the same way as it does in the authorised indication.
The company presented results from a main study involving 1,012 patients with newly diagnosed PTEN-deficient, metastatic prostate cancer that still responds to hormone treatments. Patients in this study were given either Truqap or placebo (a dummy treatment), in addition to standard treatment with abiraterone, prednisone or prednisolone and hormone therapy.
The study looked at how long the patients lived before scans showed that their cancer was getting worse.
The application was withdrawn after the European Medicines Agency had evaluated the information from the company and had prepared questions for the company. After assessing the company’s responses to the questions, the Agency still had 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 Truqap could not have been authorised for the treatment of newly diagnosed, metastatic PTEN-deficient prostate cancer that responds to hormone treatment.
The Agency considered that although the study showed a statistically significant improvement in the time patients lived before their disease got worse, the improvement was small and it was not clear whether it would provide clinically meaningful benefits. There were also no sufficient data to establish whether Truqap helped patients live longer overall. In addition, serious side effects occurred more often in patients taking Truqap compared with those taking placebo; more patients who received Truqap stopped their treatment because of side effects.
Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Truqap in the treatment of newly diagnosed PTEN-deficient prostate cancer did not outweigh its risks.
In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew its application since the Agency would not be able to conclude that the benefits outweighed the risks based on the available data.
The company informed the Agency that there are no consequences for patients in clinical trials using Truqap.
If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Truqap continues to be authorised in breast cancer.