AstraZeneca has secured US Food and Drug Administration approval for its cancer drug Truqap (capivasertib) in combination with abiraterone and prednisone, marking a major step forward in treating a hard-to-treat form of prostate cancer defined by PTEN deficiency.
The approval makes the regimen the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, a biologically aggressive subtype previously known as metastatic hormone-sensitive prostate cancer.
The decision was driven by results from the Phase III CAPItello-281 trial, which showed the combination reduced the risk of radiographic disease progression or death by 19% compared with standard therapy.
“Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, now called metastatic androgen pathway modulation-naïve or sensitive prostate cancer, experience faster progression and worse prognosis than those without PTEN deficiency," said Daniel George, investigator for the CAPItello-281 trial.
"Keeping patients with this form of prostate cancer in remission and free from disease progression as long as possible is a high priority. Today’s landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and change the course of disease.”
The study also showed a meaningful improvement in median radiographic progression-free survival: 33.2 months for patients receiving Truqap combination therapy versus 25.7 months for those on standard treatment.
“CAPItello-281 showed that for the first time, we can target a key driver of this disease to bring meaningful benefit to the one in four patients with this form of prostate cancer who urgently need biomarker-directed therapies.
"Today’s approval makes clear the importance of testing for actionable biomarkers, including PTEN deficiency, in prostate cancer," said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.
Prostate cancer remains one of the world’s most common cancers, with more than 1.4 million diagnoses annually, and an estimated one in four mAPMN/S patients carrying PTEN-deficient tumours, a genetic alteration linked to more aggressive disease and poorer outcomes.
While overall survival data from the trial are still immature, early results trend in favour of the Truqap combination. The safety profile was consistent with known effects of the drugs, with grade 3 or higher adverse events in 67% of patients, most commonly rash and hyperglycaemia.
Alongside the approval, US regulators also authorised a companion diagnostic test to identify PTEN deficiency, underscoring the shift toward biomarker-driven cancer treatment.
AstraZeneca said the approval reinforces its ambition to advance precision oncology, with Truqap now expanding beyond breast cancer into a second tumour type.
