FDAsafety guidance83% confidence
FDA AP — VANFLYTA (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck.
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 · Gastrointestinal Cancers
- Sub-indication
- General
Related signal: Patritumab Deruxtecan Study Initiated for Advanced Gastrointestinal Cancers