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 (prostate cancer) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Prostate Cancer
- Sub-indication
- Prostate Cancer
Related signal: Roche's VENTANA PTEN Assay Receives FDA Approval for Prostate Cancer Companion Diagnostic