Astrazeneca pill that can slow breast cancer cleared for NHS use

 AstraZeneca's oral therapy Truqap will soon be available for people with advanced breast cancer via the NHS in England – as long as testing is available to identify eligible patients.

AKT inhibitor Truqap (capivasertib) has been available in U.S. since November 2023. It was cleared by NICE for use in combination with standard therapy fulvestrant for HR-positive, HER2-negative metastatic breast cancer that also has one or more PIK3CA, AKT1, or PTEN mutations.

The health technology assessment (HTA) agency turned down the drug in earlier guidance published in January, citing uncertainties over its cost-effectiveness and the lack of comparison with therapies based on mTOR inhibitor everolimus and Novartis' oral PI3K inhibitor Piqray (alpelisib).

NICE said it was "pleased the company has worked with us so that we are able to recommend this promising new treatment as a good use of NHS resources and value for money for taxpayers."

Truqap can be used in patients whose disease has progressed despite prior endocrine therapy with a CDK 4/6 inhibitor and an aromatase inhibitor, according to a newly published guidance document.

Mutations in PIK3CA, AKT1, and alterations in PTEN occur frequently, affecting up to 50% of patients with advanced HR-positive breast cancer, but at the moment, genetic testing for those mutations isn't widespread, so a key objective will be to encourage screening.

Truqap was approved in the UK in July 2024 based on the 708-subject CAPItello-291 study, which included 289 patients with tumours that had an abnormal PIK3CA, AKT1 or PTEN gene. Results of the study showed that the combination of the drug and fulvestrant reduced the risk of disease progression or death compared to fulvestrant plus placebo.

Patients given Truqap experienced an average 7.3 months with the cancer not progressing versus 3.1 months for patients in the control group.

"We're delighted that NICE has recommended capivasertib with fulvestrant for use on the NHS in England, offering certain people with incurable secondary breast cancer the hope of more precious time to do what matters most to them before the disease progresses," said Claire Rowney, chief executive at Breast Cancer Now.

However, "we shouldn't overlook the fact that its initial provisional rejection meant patients have faced unnecessary delays in accessing it," she added, while calling on the Scottish Medicines Consortium (SMC) to also complete a review of the treatment speedily.

Delays of this type "happen too often and urgent action must be taken to ensure the quick approval of breast cancer drugs so they can be made available promptly to those who need them. NHS England must now put in place prompt genetic testing to ensure those eligible receive capivasertib without further delay."

https://pharmaphorum.com/news/pill-can-slow-breast-cancer-cleared-nhs-use