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: illustrates how regulators handled a comparable approval decision relevant to Regeneron; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Immunology · IL-4/IL-13
- Sub-indication
- General
Related signal: FDA grants supplemental application approval for Dupixent (BLA761055)