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11/21/2025

FDA approves (LIBTAYO) cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

LIBTAYO is now approved for adjuvant treatment of adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
LIBTAYO is also indicated:
For the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation
For the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
In combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is:
 
locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or
metastatic
As a single agent for the first-line treatment of adult patients with 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
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