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TRUQAP recommended by FDA advisory panel for PTEN-deficient prostate cancer
Friday, May 01, 2026
U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee has supported the use of TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. The panel concluded that the treatment shows a favourable benefit-risk profile based on results from the CAPItello-281 Phase III trial. The committee voted 7 in favour, with one against and one abstention.
The FDA had earlier accepted a supplemental New Drug Application for the combination therapy in August 2025, following positive trial findings presented at the European Society for Medical Oncology Congress 2025 and published in the Annals of Oncology.
The CAPItello-281 study showed that the TRUQAP combination reduced the risk of disease progression or death by 19% compared to standard treatment with abiraterone and ADT alone. Median radiographic progression-free survival improved by 7.5 months, reaching 33.2 months versus 25.7 months in the comparator group.
Further benefits were observed across secondary endpoints. The treatment delayed progression to castration-resistant disease and showed improvements in prostate-specific antigen progression and symptomatic skeletal event-free survival.
Overall survival data are not yet fully mature, although interim results indicate a trend in favour of the TRUQAP combination. The trial is ongoing to further assess survival outcomes.
The safety profile of the combination was broadly in line with known effects of the individual medicines. However, higher rates of Grade 3 or above adverse events were reported in the TRUQAP group compared to the control group. Common severe side effects included rash, high blood sugar levels, low potassium levels, diarrhoea, hypertension and anaemia.
The advisory committee provides independent recommendations to the FDA, which will consider the input as part of its review process but is not required to follow it.
Meanwhile, a regulatory application for the TRUQAP combination in this setting is also under review in the European Union based on the same Phase III trial results.
Source: businesswire.com
