BLAINTRAVENOUSINJECTABLEPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
41
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIBTAYO (cemiplimab-rwlc) is a human monoclonal antibody (mAb) that functions as a PD-1 inhibitor, blocking immune checkpoint pathways to enhance anti-tumor immunity. It is approved across 26+ oncology indications spanning solid tumors and hematologic malignancies, including NSCLC, cutaneous squamous cell carcinoma, melanoma, lymphomas, and multiple sarcomas. The drug activates T-cell mediated tumor destruction by restoring immune recognition and attack.
$6MPart D
PeakProduct is at peak lifecycle stage with established reimbursement infrastructure; commercial teams should focus on indication expansion and durability rather than launch activities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (41)
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab
Started Jun 2026
135 enrolled
Merkel Cell Carcinoma, Stage IMerkel Cell Carcinoma, Stage IINeoadjuvant Immunotherapy
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
Started Apr 2026
21 enrolled
Non-small Cell Lung Cancer Stage III
Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
Started Feb 2026
126 enrolled
Pleural Mesotheliomas
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
Started Aug 2025
79 enrolled
Colo-rectal Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.