AstraZeneca’s Truqap with Faslodex approved by Japanese MHLW

AstraZeneca’s Truqap in combination with Faslodex has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy. The approval by the Japanese Ministry of Health, Labour, and Welfare, MHLW, was based on the results from the CAPItello-291 Phase III trial published in The New England Journal of Medicine. Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Breast cancer is the most common cancer among women in Japan, and innovative, new treatment options are urgently needed. Today’s approval of Truqap, a first-in-class AKT-inhibitor, represents a significant step forward for HR-positive breast cancer treatment and an important new option for approximately fifty per cent of patients who have tumours with these specific mutations or alterations.”