FDAsafety guidance66% confidence
FDA AP — TRODELVY (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Immunomedics; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761115. Sponsor: IMMUNOMEDICS INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: SACITUZUMAB GOVITECAN-HZIY.
Supporting Context
- Therapeutic area
- Oncology · Antibody-Drug Conjugate
- Sub-indication
- General
Related signal: FDA Accepts Supplement for Trodelvy (Sacituzumab Govitecan-Hziy)