The National Institute for Health and Care Excellence (NICE) has recommended a new twice-daily tablet for some patients in England with locally advanced or metastatic breast cancer.
Capivasertib (Truqap, AstraZeneca), taken with fulvestrant, is a first-in-class kinase inhibitor. It works by blocking the action of specific biomarkers in patients with oestrogen receptor–positive breast cancer.
Trial Shows Delayed Progression
In its final draft guidance, NICE cited results from the phase 3 CAPItello-291 trial. The study showed that capivasertib plus fulvestrant extended progression-free survival to 7.3 months, compared with 3.1 months for patients on placebo plus fulvestrant.
The drug was approved by the Medicines and Healthcare products Regulatory Agency in July 2024.
The drug received European approval in summer 2024.
Aimed at High-Risk Patients
According to 2020 figures from NICE, 14.8% of the 40,192 people diagnosed with breast cancer in England had advanced-stage disease.
Hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer is incurable. Treatment aims to delay disease progression and extend survival.
Outcomes are poorer in the 40%-50% of people with gene alterations such as PIK3CA, AKT1, or PTEN. These patients often experience recurrence despite endocrine therapy.
Alternative to Existing Treatments
Currently, NICE recommends alpelisib plus fulvestrant for PIK3CA-altered disease, or exemestane plus everolimus for others.
Although capivasertib plus fulvestrant has not been directly compared with these options, NICE said that indirect comparisons suggest it performs similarly.
Higher Cost-Effectiveness Threshold
NICE applied a severity modifier, which allows a higher cost-effectiveness threshold for conditions with significant impact on quality and length of life. With a severity modifier of 1.2 applied, the combination therapy was found to be an acceptable use of NHS resources. Around 1100 patients in England are expected to benefit from the decision.
Capivasertib is priced at £5850 per 64-pack of 200 mg tablets. Fulvestrant costs £55.32 for two 250-mg prefilled syringes. The list price for 12 months of combination treatment is £77,088.
However, NICE’s approval is conditional on a confidential discount from AstraZeneca. The treatment will be funded immediately through the Cancer Drugs Fund.
Impact on Patients
Helen Knight, director of medicines evaluation at NICE, said the committee had heard from patients who described the devastating impact of advanced breast cancer. She noted the value of a well-tolerated treatment that targets AKT1 or PTEN gene alterations for which no therapies have been available.
“People with advanced breast cancer would value treatments like capivasertib that can be given when limited options exist, and because it may delay the need for chemotherapy and its associated side-effects,” Knight said in a press release.
Call for Routine Biomarker Testing
Nicholas Turner, professor of molecular oncology at the Institute of Cancer Research (ICR) and consultant oncologist at the Royal Marsden NHS Foundation Trust, London, led the CAPItello-291 trial
Commenting in a press release, the ICR, which was involved in the drug development research for capivasertib, said it “strongly welcomed” the decision.
Nicholas Turner, professor of molecular oncology at the ICR and consultant medical oncologist at the Royal Marsden NHS Foundation Trust, led the phase 3 CAPItello-291 trial. He said NICE’s approval was “immensely rewarding” and urged clinicians to test for the relevant biomarkers.
“It is now crucial that advanced breast cancer patients have their cancer tested to identify those who could benefit from this capivasertib combination,” he said in a press release.
Claire Rowney, chief executive at Breast Cancer Now, welcomed the decision but said, “We shouldn’t overlook the fact that its initial provisional rejection meant patients have faced unnecessary delays in accessing it.”
Rowney also urged the Scottish Medicines Consortium to consider the treatment “at pace.”
NICE’s final guidance is expected to be published on 15 May 2025.
The CAPItello-291 trial was sponsored and funded by AstraZeneca.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.