FDAsafety guidance66% confidence
FDA AP — INQOVI (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (bladder cancer) as Merck; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA212576. Sponsor: TAIHO ONCOLOGY. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CEDAZURIDINE, DECITABINE.
Supporting Context
- Therapeutic area
- Oncology · Bladder Cancer
- Sub-indication
- Bladder Cancer
Related signal: FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment