FDAapproval84% 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 (bladder cancer) as Astellas; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · ADC
- Sub-indication
- Bladder Cancer
Related signal: FDA grants priority review for PADCEV supplemental application