AstraZeneca: CHMP green light for Truqap + Faslodex

(CercleFinance.com) - AstraZeneca announces that Truqap (capivasertib), in combination with Faslodex (fulvestrant), has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for approval in the European Union (EU) for the treatment of adult patients with locally advanced or metastatic estrogen receptor (ER)-positive breast cancer, HER2-negative with one or more alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression during or after endocrine therapy.


In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumors presenting PI3K, AKT or PTEN alterations.

In Europe, breast cancer remains the leading cause of cancer deaths, with over 140,000 deaths in 2022 and over 550,000 new patients diagnosed in the same year.

This positive recommendation marks an important step in providing a much-needed new treatment option for around half of patients in this setting with these specific tumor biomarkers, a Senior Consultant in the Department of Medical Oncology at Vall d'Hebron University Hospital said.


Copyright (c) 2024 CercleFinance.com. All rights reserved.