FDAapproval83% 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 (breast cancer) as AstraZeneca.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- Breast Cancer
Related signal: Datroway approved in US as first TROP2-directed ADC for 1L triple-negative breast cancer