FDAsafety guidance83% confidence
FDA AP — INQOVI (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (dme) as Merck.
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 · Diffuse Large B-Cell Lymphoma
- Sub-indication
- DME
Related signal: Zilovertamab Vedotin Shows Promise in rrDLBCL with Standard Care in Phase 2/3 Study