INDICATIONS AND USAGE（适应症）

Cutaneous Squamous Cell Carcinoma

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.

Basal Cell Carcinoma

LIBTAYO is indicated for the treatment of patients:

with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

with metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. The mBCC indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for the mBCC indication may be contingent upon verification and description of clinical benefit.

Non-Small Cell Lung Cancer

LIBTAYO is indicated for the first-line treatment of patients with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic.

DOSAGE（服用剂量）

Patient Selection for NSCLC

Select patients with locally advanced or metastatic NSCLC for treatment with LIBTAYO based on PD-L1 expression on tumor cells.

Recommended Dosage

The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

ADVERSE REACTIONS（不良反应）

Severe and Fatal Immune-Mediated Adverse Reactions

Infusion-Related Reactions

Complications of Allogeneic HSCT

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/4347ae1f-d397-4f18-8b70-03897e1c054a/spl-doc?hl=cemiplimab

Libtayoinformation