Libtayo receives FDA approval for NSCLC with high PD-L1 expression

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FDA has approved Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) 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.

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I have spent over 20 years running a tumor imaging metrics core at an academic cancer center. In that time, I have watched clinical trial enrollment concentrate at a relatively small number of flagship academic institutions. Unfortunately, trials do not propagate well to the community sites where most patients prefer to receive care. The explanations usually offered for why this happens have never fully accounted for what I observed.

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