UNLOXCYT cosibelimab

Drug Class

PD-L1 antagonist monoclonal antibody

Mechanism

Binds to PD-L1 on tumor cells and antigen-presenting cells, blocking its interactions with PD-1 and B7.1 to restore T-cell antitumor immune responses.

Approved Indication

Metastatic or locally advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or curative radiation, per its FDA approval.

What This Means For Patients

UNLOXCYT is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2024) — Sources

Pivotal Clinical Evidence

• Study CK-301-101 — Clingan et al., J Immunother Cancer 2023 (NCT03212404) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cosibelimab-ipdl-cutaneous-squamous-cell-carcinoma
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761330