Claire Rowney, chief executive of Breast Cancer Now, said:
“The provisional rejection of such a promising new secondary breast cancer treatment is a huge blow for people who desperately need more time before their cancer progresses to do what matters most to them.[1]
“Capivasertib would bring a vital treatment option for people with alterations in the PIK3CA, AKT1 or PTEN genes, which affect up to half of people with hormone receptor positive advanced breast cancer.
“Recognised by NICE as an effective treatment, it’s deeply frustrating that uncertainties in the evidence and economic modelling mean that capivasertib is being kept out of reach of people who need it. Some of them won’t have any other targeted options available for the particular genetic changes in their tumours.
“NICE and Astra Zeneca must urgently work together to address the uncertainties identified and see a solution reached that makes capivasertib available to everyone it could benefit.”
ENDS
Capivasertib with fulvestrant has been provisionally rejected by NICE for treating people with HR-positive, HER2-negative advanced breast cancer with one or more PIK3CA, AKT1 or PTEN alterations, that has recurred or progressed on endocrine treatment.
[1] Capivasertib plus fulvestrant increased median progression free survival by 4.2 months compared to placebo plus fulvestrant for people with PI3K/AKT pathway altered tumours.