has received approval for Truqap (capivasertib) in combination with Faslodex (fulvestrant) in the European Union (EU) for the treatment of certain advanced breast cancer cases in adults. This marks a significant development for patients with oestrogen receptor (ER)-positive, HER2-negative breast cancer, who have experienced disease progression after endocrine-based therapy. The gold standard of business intelligence.
The European Commission’s decision follows a favourable recommendation from the Committee for Medicinal Products for Human Use (CHMP). It is underpinned by results from the Phase III CAPItello-291 trial, which demonstrated a 50% reduction in the risk of disease progression or death when Truqap was used in combination with Faslodex, compared to Faslodex with placebo. The double-blinded and randomised trial, which enrolled 708 patients, showcased a median progression-free survival of 7.
3 months for the combination therapy versus 3.1 months for the placebo group. The safety profile observed was consistent with previous studies of the combination.
It focused on the efficacy of Truqap in conjunction with Faslodex against a placebo plus Faslodex regimen. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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