LIBTAYO
Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of specific advanced skin and lung cancers. It is used for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) and basal cell carcinoma (BCC), as well as for the adjuvant treatment of high-risk CSCC. The therapy also serves as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) lacking EGFR, ALK, or ROS1 aberrations. It is primarily prescribed for patients who are not candidates for curative surgery or radiation, or those who have previously received specific targeted therapies.
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.
Details
- Status
- Prescription
- First Approved
- 2018-09-28
- 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 Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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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
ProIndications & Usage
FDA Label (PDF)LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.