regulatory
confidence high
sentiment positive
materiality 0.85
FDA approves Fortress subsidiary Checkpoint's UNLOXCYT for advanced cSCC
Fortress Biotech, Inc.
- FDA approved UNLOXCYT (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults not candidates for curative surgery/radiation.
- UNLOXCYT is the first and only PD-L1 blocking antibody approved for this indication.
- Approval based on objective response rates and duration of response from Study CK-301-101 (NCT03212404).
- Checkpoint Therapeutics is a majority-controlled subsidiary of Fortress Biotech, Inc.