FDAsafety guidance66% confidence
FDA AP — VANFLYTA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Daiichi Sankyo; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA216993. Sponsor: DAIICHI SANKYO INC. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: QUIZARTINIB DIHYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Oncology · FLT3 Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for VANFLYTA (Quizartinib)