FDAsafety guidance83% confidence
FDA AP — KEYTRUDA QLEX (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (melanoma) as Merck Sharp & Dohme LLC.
Regulatory Analysis
Application BLA761467. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: PEMBROLIZUMAB, BERAHYALURONIDASE ALFA-PMPH.
Supporting Context
- Therapeutic area
- Oncology · Uveal Melanoma
- Sub-indication
- Melanoma
Related signal: Phase II Trial of Olaparib and Pembrolizumab in Advanced Uveal Melanoma Initiated