AstraZeneca's Truqap approved for NHS breast cancer treatment

AstraZeneca's Truqap (capivasertib) has been officially approved for use within the National Health Service (NHS) in both England and Wales. This approval introduces a promising targeted therapy that has shown the potential to enhance progression-free survival (PFS) in patients battling breast cancer. The National Institute for Health and Care Excellence (NICE), which serves as the NHS's financial regulator, has given the green light for Truqap's use in conjunction with AstraZeneca's existing breast cancer medication, Faslodex (fulvestrant). This combination therapy is designated for adults diagnosed with hormone receptor (HR)-positive HER2-negative breast cancer, especially those with one or more gene alterations in PIK3CA, AKT1, or PTEN, and whose cancer is locally advanced or metastatic.

NICE projects that approximately 1,100 patients will initially benefit from this new twice-daily tablet regimen. The Institute of Cancer Research (ICR) in London anticipates that this combination therapy could eventually assist around 3,000 patients annually. With its approval, Truqap is poised to become a significant revenue source for AstraZeneca, with forecasts suggesting the drug will achieve blockbuster status by 2027 and global sales nearing $2 billion by 2031, according to GlobalData’s Pharma Intelligence Centre. Besides the UK, Truqap has also gained approval in the United States, the European Union, Japan, and other regions.

The HR-positive HER2-negative breast cancer pharmaceutical market includes other key players like Pfizer's Ibrance (palbociclib), Eli Lilly's Verzenio (abemaciclib), and Novartis' Kisqali (ribociclib). Breast cancer remains the most prevalent cancer in the UK, affecting one in seven women. Thanks to advancements in treatment over recent decades, 75% of patients can now expect to survive for a decade or more post-diagnosis. Among breast cancer types, HR-positive HER2-negative is the most common.

The approval of Truqap follows the results from the Phase III CAPItello-291 trial, which demonstrated that in 708 women with HR-positive HER2-negative breast cancer, Truqap significantly extended the time before cancer progression. Patients receiving the combination of Truqap and Faslodex experienced a median PFS of 7.3 months, compared to just 3.1 months for those on hormone therapy alone.

The availability of Truqap through the NHS has been hailed as a significant achievement by Professor Kristian Helin, chief executive of the ICR. "This announcement is a triumph that will enhance treatment for patients with the most common type of advanced breast cancer. Approximately half of these patients have mutations in one or more genes, and for them, Truqap offers an opportunity to halt disease progression. I am thrilled that NHS patients in England and Wales who are in dire need of better treatment options now have expanded access to the drug," Professor Helin remarked.

Currently, patients in the UK with advanced HR-positive HER2-negative breast cancer are often offered Faslodex or chemotherapy. However, Faslodex alone frequently falls short, and chemotherapy is associated with significant side effects, as highlighted by the ICR. Helen Knight, NICE's director of medicines evaluation, emphasized the value of treatments like Truqap for those with limited options, noting its potential to delay the need for chemotherapy and its related side effects. Truqap operates by inhibiting all three isoforms of the AKT protein, crucial for cancer cell growth and multiplication. While NICE acknowledged that no direct clinical trials have compared this new combination therapy to existing regimens, indirect comparisons suggest that it is not inferior.

The recommendation from NICE reflects a reversal of its earlier position when the agency hesitated due to concerns about cost-effectiveness. Claire Rowney, chief executive of Breast Cancer Now, pointed out that this initial stance resulted in "unnecessary delays in accessing" the treatment for patients. She stressed the urgent need for NHS England to implement prompt genetic testing to ensure eligible patients can receive Truqap without further delay.