FDAsafety guidance66% confidence
FDA AP — BIZENGRI (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Amgen; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761352. Sponsor: MERUS N.V.. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: ZENOCUTUZUMAB-ZBCO.
Supporting Context
- Therapeutic area
- Oncology · NRG1 Fusion-Positive Cholangiocarcinoma
- Sub-indication
- General
Related signal: FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma