CHMP positive recommendation for capivasertib (Truqap) for the treatment of locally advanced or metastatic breast cancer with one or more specific genetic mutations: PIK3CA, AKT1, or PTEN.- AstraZeneca.
The CHMP has given a positive opinion for capivasertib (Truqap) for the treatment of locally advanced or metastatic breast cancer with one or more specific genetic mutations: PIK3CA, AKT1, or PTEN.
Capivasertib is an AKT inhibitor that targets the cancer-driving protein molecule AKT — also known as protein kinase B or PKB. It locks into a cavity in the target protein, like a molecular key, to block the protein's cancer-driving activity. It is taken orally and is used in combination with fulvestrant.
The CAPtello-291 trial found that capivasertib-fulvestrant therapy resulted in significantly longer progression-free survival than did treatment with fulvestrant alone among patients with hormone receptor–positive advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor. In the overall population, the median progression-free survival was 7.2 months in the capivasertib-fulvestrant group, compared with 3.6 months in the placebo-fulvestrant group.
The benefit of Truqap in combination with fulvestrant is an improved progression-free survival (PFS) in patients with ER?positive, HER2?negative advanced breast cancer with one or more PIK3CA/AKT1/PTEN alterations following recurrence or progression on or after an endocrine-based therapy, when compared to fulvestrant and placebo. The most common side effects of Truqap are diarrhoea, rash, nausea, fatigue, vomiting, stomatitis, hyperglycaemia, headache and decreased appetite.
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