Name

Cemiplimab

Alternate Names

Libtayo
Cemiplimab-rwlc

Abbreviations

None

Category

Biologic therapy (BRM, immunotherapy)

Subcategory

Monoclonal antibody

NSC Number

None

Primary Site

None

Histology

Non small cell lung cancer (NSCLC), SCC, BCC

Remarks

November 8, 2022 New indication: FDA Administration approved cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

February 22, 2021 FDA approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced 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.

February 9, 2021 FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma.

9/28/18: The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC

Coding

This drug should be coded
Glossary