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 an immunotherapy targeting the PD-L1 pathway for patients with advanced cutaneous squamous cell carcinoma (skin cancer) that cannot be treated with surgery or radiation. It helps reactivate immune cells to target the tumor, and is available at Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2024) — source

Pivotal Clinical Evidence

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

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