TRUQAP® (capivasertib) recommended by the FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee has recognized a favourable benefit-risk profile for AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. 

MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial, Daniel George said, Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. 

According to Towards Healthcare, the Capivasertib market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 584.78 million in 2026 to approximately USD 3109.09 million by 2035, representing a compound annual growth rate (CAGR) of 21.05% from 2026 to 2035. Growth is driven by its effectiveness in treating advanced or metastatic cancer, particularly those resistant to conventional therapies, early stages of development, but its growth potential is significant, especially as regulatory bodies approve more cancer therapies and treatments gain broader clinical acceptance. 

About TRUQAP (capivasertib) 

FDA-approved AKT inhibitor used with fulvestrant to treat HR-positive, HER2-negative advanced or metastatic breast cancer with specific genetic mutations. It is Truqap is indicated for adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer who have PIK3CA, AKT1, or PTEN gene alterations detected by an FDA-approved test. 

Truqap represents a targeted therapy option for patients with specific genetic alterations in advanced breast cancer, offering improved progression-free survival when combined with fulvestrant. Regular monitoring and adherence to dosing schedules are essential to manage side effects and maximize treatment benefits. 

Executive Vice President, Oncology Haematology R&D, AstraZeneca, Susan Galbraith said CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. The Committee's recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the TRUQAP combination verifies its potential to address this significant need and optimize outcomes for patients.  

A recent report by Towards Healthcare highlights that the Capivasertib market is witnessing growth due to the growth due to its effectiveness in treating various cancers, particularly those resistant to conventional therapies. The global capivasertib market is on the rise, largely driven by its promising clinical results, ongoing research, and expanding interest from pharmaceutical companies seeking to improve cancer treatment regimens.