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 (her2) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · HER2-positive Breast Cancer
- Sub-indication
- HER2
Related signal: Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications