Cutaneous squamous cell carcinoma (metastatic or locally advanced not candidate for curative surgery/radiation); Basal cell carcinoma (locally advanced or metastatic previously treated with hedgehog pathway inhibitor or for whom HHI is not appropriate); Non-small cell lung cancer (first-line, PD-L1 ≥50%, no EGFR/ALK/ROS1 aberrations); Cervical cancer (recurrent or metastatic with PD-L1 CPS ≥1, with chemo ± bevacizumab)
350 mg IV every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months
Infusion time: Over 30 minutes
Injection: 50 mg/mL solution in 7 mL (350 mg) single-dose vial
Refer to the complete prescribing information for contraindications. Libtayo prescribing should account for patient-specific factors including hypersensitivity to the active ingredient or any excipients.
Important warnings and precautions are detailed in the full prescribing information. Healthcare providers should review all boxed warnings, if applicable, and precautionary guidance before prescribing Libtayo.
Fatigue (29%), rash (25%), diarrhea (18%), musculoskeletal pain (17%), nausea (13%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Cemiplimab is a human IgG4 monoclonal antibody that binds to PD-1 and blocks its interactions with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the anti-tumor immune response.
Half-life: 19.4 days. Clearance: 0.24 L/day. Vd: 5.2 L. Steady-state by ~4 months with q3w dosing. Linear PK across 1-10 mg/kg. Not significantly affected by age, body weight, or mild renal impairment.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Libtayo has FDA-approved indications across the following cancer types covered on PipelineEvidence: