OnCo
drugsProductNot mapped hereapproved

Cosibelimab

Cosibelimab is a PD-L1 antibody approved in December 2024 for advanced cutaneous squamous cell carcinoma, offering a third immunotherapy choice.

Pivotal phase 1 expansion: 47% response in metastatic cSCC and 48% in locally advanced disease with durable responses. Approval delayed by a 2023 CRL over manufacturing; approved December 2024. Sun Pharma acquired Checkpoint Therapeutics in 2025.

Schematic of the modality · Anti-PD-L1 monoclonal antibody (IgG1, ADCC-competent) · not a molecule; see the Immune checkpoint inhibitors page
How it works, step by step · animated schematic, not to scale
Immune checkpoint inhibitors
Modality
Anti-PD-L1 monoclonal antibody (IgG1, ADCC-competent)
Mechanism
Blocks PD-L1 while retaining an active Fc for antibody-dependent cellular cytotoxicity against PD-L1-expressing cells.
Brand / code
Unloxcyt
Medicare
Part B (clinician-administered)

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.

Commercial insurance
covered with prior authorisation

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.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: cosibelimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. Dec 2023Complete response letterUS

    Complete response letter citing third-party manufacturing inspection findings

  2. 13 Dec 2024ApprovalUS

    Approved for cSCC

Approvals

RegionYearIndication
US2024Metastatic or locally advanced cutaneous SCC not curable by surgery or radiation

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
1 studies0 recruiting1 Phase 3
Search “Cosibelimab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Cosibelimab
intervention: Cosibelimab
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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