LIBTAYO (cemiplimab-rwlc)
LIBTAYO is indicated for the treatment of Metastatic cutaneous squamous cell carcinoma; Locally advanced cutaneous squamous cell carcinoma; Adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation; Locally advanced basal cell carcinoma; Metastatic basal cell carcinoma; First-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with platinum-based chemotherapy; First-line monotherapy for locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%).
How LIBTAYO Works
Cemiplimab-rwlc is a recombinant human monoclonal antibody that binds to the PD-1 receptor on T cells. Normally, when PD-1 ligands (PD-L1 and PD-L2) bind to this receptor, they inhibit T-cell proliferation and the immune response, a mechanism tumors use to evade detection. By blocking these interactions, the drug releases the inhibition of the immune system, specifically the anti-tumor immune response. This reactivation allows the immune system to recognize and decrease the growth of tumor cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-28
- Revenue
- $50M (Q2-2022)
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
LIBTAYO Approval History
What LIBTAYO Treats
7 indicationsLIBTAYO is approved for 7 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic cutaneous squamous cell carcinoma
- Locally advanced cutaneous squamous cell carcinoma
- Adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation
- Locally advanced basal cell carcinoma
- Metastatic basal cell carcinoma
- First-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with platinum-based chemotherapy
- First-line monotherapy for locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%)
LIBTAYO Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
LIBTAYO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LIBTAYO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LIBTAYO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LIBTAYO
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03409614 results posted | R2810-ONC-16113 2017-001311-36 | Ph 3 | completed | Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer |
| NCT06449313 NEO-SURG | STUDY00007668 | Ph 2 | recruiting | Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement |
| NCT04975152 | MCC-20794 | Ph 1 | active not recruiting | Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma |
| NCT03951831 | AAAS1863 | Ph 2 | active not recruiting | REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer |
| NCT04006119 results posted | ATI001-204 | Ph 2 | terminated | Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma |
| NCT05729139 | 2021-RAB-001 | Ph 1 | withdrawn | Cemiplimab/Peg-Interferon-α in Advanced CSCC |
| NCT04242173 results posted | MCC-20114 | Ph 2 | terminated | Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC |
| NCT04831450 | 20200543 | Ph 2 | withdrawn | Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) |
| NCT03002376 | R2810-ONC-1606 2016-002755-16 | Ph 1 | completed | An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1) |
| NCT03198130 | R2810-ONC-1655 2016-004029-18 | Ph 1 | completed | An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1) |
| NCT02520245 | R2810-ONC-1425 | Ph 1 | withdrawn | Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIBTAYO FDA Label Details
Indications & Usage
FDA Label (PDF)LIBTAYO is indicated for the treatment of Metastatic cutaneous squamous cell carcinoma; Locally advanced cutaneous squamous cell carcinoma; Adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation; Locally advanced basal cell carcinoma; Metastatic basal cell carcinoma; First-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with platinum-based chemotherapy; First-line monotherapy for locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%).
Pro Intelligence Preview
Deep insights for LIBTAYO
Revenue Insights
- • Q2-2022: $50M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 11 total trials
- • Stage: Stable
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment