FDA Approves Label Update for UNLOXCYT™ Based on Longer-Term Data Showing Improved Clinical Outcomes in Advanced Cutaneous Squamous Cell Carcinoma
The FDA has approved an updated label for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. The updated label incorporates long-term follow-up data from the pivotal CK-301-101 trial, which showed patients receiving UNLOXCYT experienced durable clinical responses. The most common adverse reactions were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. Two patients (0.9%) experienced high-grade immune-mediated adverse reactions (imARs); both were Grade 3 dermatologic imARs. There were no treatment-related deaths.
Key Highlights
- FDA approves label update for UNLOXCYT™ based on longer-term data
- Durable clinical responses observed in the CK-301-101 trial
- At least 50% of patients achieved the primary endpoint of objective response
- Median duration of response not reached in either group at the time of analysis
- Updated label reinforces UNLOXCYT as an evolution in checkpoint inhibition