- AstraZeneca
- 15 June 2026 08:31:49
Source: Sharecast
Astrazeneca said the approval was based on results from its Phase III CAPItello‑281 trial, which showed the combination cut the risk of the disease worsening or patients dying by 19%. Median progression‑free survival was 33.2 months on the Truqap regimen, compared with 25.7 months for those on standard therapy.
The FTSE 100-listed firm said the safety profile was broadly in line with expectations, with the most common severe side effects including rash and high blood sugar. At the same time, the FDA approved a companion diagnostic to identify patients whose tumours lack PTEN.
Prostate cancer remains the second most common cancer in men worldwide, with more than 1.4m cases diagnosed each year. Astrazeneca added that around 200,000 patients globally, 35,000 of which were in the US, were diagnosed with this specific metastatic form each year.
A regulatory application for the Truqap combination was also under review in the EU.
Dave Fredrickson, executive vice president of Astrazeneca's oncology haematology business unit, said: "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."
As of 0830 BST, Astrazeneca shares were up 0.15% at 13,482p.
Reporting by Iain Gilbert at Sharecast.com
See latest RNS at Investegate