AstraZeneca, a global pharmaceutical company, has gained approval for Truqap (capivasertib) in combination with Faslodex (fulvestrant) in treating adult patients with oestrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer by the European Union.
It can be administered in patients with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression after an endocrine-based regimen.
The approval stems from the results of the CAPItello-291 Phase III trial, where Truqap-Faslodex reduced the risk of disease progression or death by 50% versus Faslodex plus placebo in patients with PI3K, AKT or PTEN alterations.
Mafalda Oliveira, Vall d’Hebron University Hospital, and Senior Clinical Investigator of the Vall d’Hebron Institute of Oncology’s Breast Cancer Group in Barcelona, Spain, said: “Patients with advanced ER-positive breast cancer typically experience tumour progression or resistance with widely used endocrine-based treatment regimens, and there is an urgent need to provide them more time with their disease under control. This approval is welcome news for approximately half of ER-positive breast cancer patients in Europe who have tumours with these biomarkers, and it is important for clinicians to test and identify eligible patients who may be able to benefit from this combination.”