Truqap (capivasertib) — Medica
hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with a PIK3CA, AKT1, or PTEN alteration
Initial criteria
- age ≥ 18 years
- disease is locally advanced or metastatic
- hormone receptor-positive (HR+) disease
- human epidermal growth factor receptor 2 (HER2)-negative disease
- presence of at least one PIK3CA, AKT1, or PTEN alteration detected by an FDA-approved test
- EITHER (a) progression with at least one endocrine-based regimen in the metastatic setting AND progression with at least one cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting OR (b) recurrence on or within 12 months of completing adjuvant endocrine therapy
Approval duration
1 year