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.
- 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.
- 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.
- Dec 2023Complete response letterUS
Complete response letter citing third-party manufacturing inspection findings
- 13 Dec 2024ApprovalUS
Approved for cSCC
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Metastatic or locally advanced cutaneous SCC not curable by surgery or radiation |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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