On November 8th, 2022, the Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc) for treatment of non-small cell lung cancer where there are no changes in ALK, EGFR or ROS1 in combination with platinum doublet chemotherapy. The FDA based their approval on the results of the clinical trial Study 16113 which showed that a high percentage of patients receiving Libtayo with chemotherapy experienced better outcomes as measured by higher overall survival and progression free survival when compared to those taking chemotherapy and a placebo. Additionally, patients receiving Libtayo and chemotherapy were more likely to respond to treatment.

The new labeling approval for Libtayo gives a new subset of patients access to the drug.

Learn more about this approval in the full FDA press release.