FDAsafety guidance72% confidence
FDA AP — INQOVI (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Bristol-Myers Squibb.
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 · Immunotherapy
- Sub-indication
- Lung Cancer
Related signal: Phase III Trial of Nivolumab Post-Surgery in Non-Small Cell Lung Cancer