FDAsafety guidance83% confidence
FDA AP — KEYTRUDA (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Merck.
Regulatory Analysis
Application BLA125514. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: PEMBROLIZUMAB.
Supporting Context
- Therapeutic area
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Merck and Gilead Discontinue Phase 3 Study of Trodelvy and KEYTRUDA in NSCLC
Source
FDA document
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