Cosibelimab is a PD-L1 antibody approved in December 2024 for advanced cutaneous squamous cell carcinoma, offering a third immunotherapy choice.
Cosibelimab is an IgG1 monoclonal antibody against PD-L1 that keeps a functional Fc region, so in addition to blocking the PD-1/PD-L1 checkpoint it can trigger antibody-dependent cellular cytotoxicity against PD-L1-expressing cells. It is used for metastatic or locally advanced cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation. In the pivotal phase 1 expansion cohorts the response rate was 47% in metastatic disease and 48% in locally advanced disease, with durable responses. A December 2023 complete response letter citing third-party manufacturing inspection findings delayed approval, and the FDA approved it in December 2024 as a third immunotherapy option after cemiplimab and pembrolizumab. Sun Pharma acquired Checkpoint Therapeutics in 2025. Whether the ADCC-competent Fc adds clinical benefit over standard PD-1 antibodies has not been tested head to head.
Blocks PD-L1 while retaining an active Fc for antibody-dependent cellular cytotoxicity against PD-L1-expressing cells. Connects to PD-L1.
1.Cosibelimab binds PD-L1.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved for cutaneous squamous cell carcinoma.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: cosibelimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Complete response letter citing third-party manufacturing inspection findings
Approved for cSCC
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Metastatic or locally advanced cutaneous SCC not curable by surgery or radiation |
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Query for this drug: (TITLE:"Cosibelimab" OR ABSTRACT:"Cosibelimab" OR TITLE:"Unloxcyt" OR ABSTRACT:"Unloxcyt") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cosibelimab, not a curated reading list.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma.
Shares CK-301-101, Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.
Shares PD-1 / PD-L1 immune checkpoint & T-cell activation, PD-L1.
Shares Advanced cutaneous squamous cell carcinoma, Cutaneous squamous cell carcinoma, Immune checkpoint inhibitors.