ICR Research Legacy Supports Capivasertib Approval for Aggressive Form of Prostate Cancer

ICR Research Legacy Supports Capivasertib Approval for Aggressive Form of Prostate Cancer

(IN BRIEF) The Institute of Cancer Research, London, has welcomed the US FDA approval of capivasertib for patients with PTEN-deficient advanced prostate cancer, marking the first regulatory approval of the targeted drug in prostate cancer. Capivasertib blocks AKT, a cancer-driving protein involved in the PI3 kinase pathway, and is designed to target a more aggressive form of advanced prostate cancer associated with poor outcomes. The FDA decision was based on the phase III CAPItello-281 trial, which showed that adding capivasertib to standard treatment with abiraterone delayed cancer progression, with patients receiving the combination living a median of 33.2 months before their cancer worsened, compared with 25.7 months for those receiving abiraterone alone. The drug’s development builds on decades of research at the ICR into AKT biology, including the publication of AKT’s 3D structure in 2002 and subsequent fragment-based drug discovery work with Astex Pharmaceuticals, later licensed to AstraZeneca. The ICR said the approval demonstrates how fundamental cancer research can lead to new treatment options for patients, while raising hopes for potential future approval in Europe and the UK.

(PRESS RELEASE) LLONDON, 19-Jun-2026 — /EuropaWire/ — The Institute of Cancer Research, London, has welcomed the US Food and Drug Administration’s approval of capivasertib for the treatment of a form of advanced prostate cancer, describing the decision as an important step forward for patients with PTEN-deficient disease.

The approval marks the first regulatory authorisation for capivasertib in prostate cancer and means eligible patients in the United States with PTEN-deficient advanced prostate cancer will be able to access the targeted therapy.

The decision has also raised hopes that capivasertib could become available for prostate cancer patients in other regions, including Europe and the UK. A regulatory application for use of the medicine in this setting is currently under review in the European Union.

Prostate cancer is the second most common cancer in men and the fifth leading cause of male cancer deaths globally. More than 1.4 million people are diagnosed with the disease each year. Around 200,000 patients worldwide, including 35,000 in the US, are diagnosed annually with advanced prostate cancer.

Approximately one quarter of patients with advanced prostate cancer have PTEN-deficient tumours, a more aggressive form of the disease associated with poorer outcomes. Capivasertib is designed to target this biology by blocking AKT, a cancer-driving protein that transmits growth signals through the PI3 kinase pathway.

The FDA approval was based on results from the international phase III CAPItello-281 trial. The study showed that adding capivasertib to standard treatment with abiraterone delayed cancer growth or spread in patients with PTEN-deficient advanced prostate cancer.

Patients who received capivasertib plus abiraterone lived for a median of 33.2 months before their cancer worsened, compared with 25.7 months for patients treated with abiraterone alone. This represents a difference of 7.5 months. Early data also suggest the combination may help patients live longer overall, although further follow-up is needed to confirm the full survival benefit.

The development of capivasertib has roots in decades of fundamental cancer research at The Institute of Cancer Research. ICR scientists studied how AKT is regulated and, in 2002, published the 3D structure of the protein and showed how it is activated. This work helped explain how AKT drives cancer behaviour and provided a structural basis for drug discovery.

Researchers in the ICR’s Centre for Cancer Drug Discovery, supported by Cancer Research UK, established a drug discovery project and worked with Astex Pharmaceuticals to design small-molecule inhibitors targeting AKT. The collaboration used fragment-based drug design, a technique in which small chemical fragments are identified and gradually developed into more potent inhibitors.

In 2005, prototype drug compounds discovered by the ICR and Astex showed promising activity against a range of human tumours grown in mice and were licensed to AstraZeneca. AstraZeneca later announced the discovery of capivasertib in 2010 and continued developing the drug as a potential treatment for several cancer types.

Capivasertib has already achieved regulatory success in breast cancer. Following positive results from the phase III CAPItello-291 trial, the FDA approved the drug in 2023 for advanced ER-positive, HER2-negative breast cancer with PI3 kinase pathway mutations. In April 2025, NICE recommended capivasertib in combination with fulvestrant for eligible patients in England and Wales with HR-positive, HER2-negative advanced or metastatic breast cancer with PIK3CA, AKT1 or PTEN mutations.

ICR researchers have also continued to explore the potential of AKT inhibitors such as capivasertib in prostate cancer. A study published in Nature Communications in 2025 showed that combining AKT inhibition with other targeted treatments could kill cancer cells and slow tumour growth in models of advanced disease.

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, said the FDA approval is an important step forward for patients with advanced prostate cancer, particularly those with PTEN-deficient disease who urgently need more targeted treatment options. He said capivasertib is the result of decades of research into how cancer cells grow and survive, and that the approval shows how scientific advances can translate into new patient treatments.

Professor Paul Workman OBE, Harrap Professor of Pharmacology and Therapeutics at The Institute of Cancer Research, former ICR Chief Executive and a researcher involved in the AKT drug discovery project, said the approval demonstrates how fundamental discovery science can lead to new treatment approaches. He said ICR research helped establish AKT as a key cancer driver and that the institute’s work on the protein’s 3D structure guided efforts to design drugs capable of blocking it.

Workman added that collaboration with Astex Pharmaceuticals and the use of fragment-based design helped create advanced prototype drugs that showed proof-of-concept activity in human tumour models, including models where the PI3 kinase pathway was activated through PTEN deficiency.

The ICR said the approval of capivasertib for advanced prostate cancer builds on the drug’s earlier success in breast cancer and highlights the value of long-term academic, charity and industry collaboration in bringing targeted cancer treatments from early discovery to patient benefit.

Media Contact:

Tel: 0203 437 3502
email: mediaoffice@icr.ac.uk

SOURCE: The Institute of Cancer Research