AstraZeneca PLC (LSE:AZN) has secured US approval for a new breast cancer treatment, Truqap (capivasertib), to be used in combination with Faslodex (fulvestrant).
It brings hope for a specific group of sufferers: adult women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic forms of the disease, who have specific genetic biomarkers (PIK3CA, AKT1, or PTEN).
This treatment is particularly for those who have seen their cancer progress after hormone-based therapies or within 12 months of completing adjuvant therapy.
The US Food and Drug Administration's decision is based on the results of the CAPItello-291 phase III trial, which showed that the combination of Truqap and Faslodex reduced the risk of disease progression or death by 50% compared to Faslodex alone.
In the trial, women treated with the combination therapy had a median progression-free survival of 7.3 months, versus 3.1 months for those on Faslodex alone.
Breast cancer is the most common cancer worldwide and a leading cause of cancer-related deaths in women. HR-positive breast cancer, which is sensitive to hormones and represents over 65% of all breast cancer cases, often develops resistance to standard hormone therapies.
The approval of Truqap in combination with Faslodex offers a new treatment option for women with this challenging form of breast cancer.