FDAsafety guidance54% 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 safety guidance precedent in the same sub-indication (bladder cancer) as Merck.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Bladder Cancer
- Sub-indication
- Bladder Cancer
Related signal: European Commission Approves KEYTRUDA Plus Padcev for Cisplatin-Ineligible Bladder Cancer