NEW YORK – AstraZeneca on Thursday said the European Commission approved its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) as a treatment for patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer bearing one or more PIK3CA, AKT1, or PTEN alterations after recurrence or progression on an endocrine-based therapy regimen.
The commission's decision is based on the Phase III CAPItello-291 trial in which Truqap-Faslodex reduced the risk of disease progression or death by 50 percent compared to Faslodex alone. Patients on Truqap-Faslodex had a median progression-free survival of 7.3 months compared to 3.1 months for the control group.
"Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumors harboring these specific biomarkers," Dave Fredrickson, executive VP of AstraZeneca's oncology business, said in a statement.
About 50 percent of patients with advanced hormone receptor-positive breast cancer have alterations in PIK3CA, AKT1, or PTEN, and they typically develop resistance to standard first-line therapies. In March, the US Food and Drug Administration approved Roche subsidiary Foundation Medicine's FoundationOne CDx as a companion diagnostic to identify breast cancer patients who have such alterations.
Truqap-Faslodex is already approved in the US, Japan, and several other countries in this setting.