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 (melanoma) 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 · Immunotherapy
- Sub-indication
- Melanoma
Related signal: Merck Reports Promising Long-Term Data for KEYTRUDA and Intismeran in Oncology at ASCO 2026