FDAapproval54% confidence
FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
Source: FDA
Why This Matters
Why this matters: sets a approval precedent in the same sub-indication (prostate cancer) as Bayer.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Prostate Cancer
- Sub-indication
- Prostate Cancer
Related signal: Study on Real-world Use of Darolutamide in Metastatic Hormone-sensitive Prostate Cancer