Libtayo Receives New Lung Cancer Indication

February 22, 2021 – The U.S. FDA has approved a new indication for Libtayo® (cemiplimab-rwlc), manufactured by Regeneron Pharmaceuticals. The drug is now indicated for first-line treatment of patients diagnosed with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations. Under the indication, the patient’s disease must be either metastatic or locally advanced (where patients are not candidates for surgical resection or definitive chemoradiation).

NSCLC accounts for up to 85% of all lung cancer diagnoses in the United States. The five-year survival rate is dependent on the stage of the disease, but a high PD-L1 expression is associated with a worse prognosis and can interfere with the immune system’s ability to fight cancer. Libtayo works by blocking the function of PD-L1, helping the immune system be more effective in attacking and killing cancerous cells.

In clinical studies, Libtayo reduced patients’ risk of death by up to 43% compared to treatment with chemotherapy. Recommended dosing is 350mg administered via 30-minute intravenous infusion once every three weeks until disease progression or unacceptable toxicity occur.

Libtayo first received FDA approval in 2018. It is also indicated to treat cutaneous squamous cell carcinoma and basal cell carcinoma.