FDA Approves Truqap
On November 16, 2023, the FDA approved capivasertib (Truqap™, AstraZeneca Pharmaceuticals) in combination with fulvestrant (Faslodex®) and a companion diagnostic test for the treatment of people with hormone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) MBC with a PIK3CA, AKT1, or PTEN mutation who have received at least one type of hormone therapy. This approval is based on results from the phase 3 CAPItello-291 trial.
- US Food and Drug Administration: FDA approves capivasertib (Truqap™) and a companion diagnostic test for people with HR+, HER2- MBC and certain genetic mutations
- Breastcancer.org: FDA approves capivasertib (Truqap™) for treatment of people with HR+, HER2- MBC who have received at least one type of hormone therapy and who have certain genetic mutations