FDAapproval95% confidence
FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (ild) as Lipfendra; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Cardiology · Cholesterol Management
- Sub-indication
- Ild
Related signal: FDA Approves First Oral PCSK9 Inhibitor Lipfendra for High Cholesterol