FDAsafety guidance83% confidence
FDA AP — HERCEPTIN HYLECTA (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (melanoma) as Roche.
Regulatory Analysis
Application BLA761106. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TRASTUZUMAB AND HYALURONIDASE-OYSK.
Supporting Context
- Therapeutic area
- Oncology · NRAS-mutant Melanoma
- Sub-indication
- Melanoma
Related signal: Genentech's Belvarafenib Trial in NRAS-mutant Advanced Melanoma Initiated