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 (cardiology) as RK Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Pulmonology · PAH
- Sub-indication
- Hypertension
Related signal: FDA Grants Approval for Selexipag Application ANDA214055