FDAsafety guidance66% confidence
FDA AP — ALECENSA (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA208434. Sponsor: HOFFMANN-LA ROCHE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ALECTINIB HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Oncology · ALK Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplemental Application for ALECENSA (Alectinib Hydrochloride)