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Cemiplimab Approved in Europe for Cutaneous Squamous Cell Carcinoma

Jason M. Broderick @jasoncology
Published: Monday, Jul 01, 2019

Dr Axel Hauschild, MD, PhD

Axel Hauschild, MD, PhD
The European Commission approved cemiplimab (Libtayo) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals and Sanofi, the manufacturers of the PD-1 inhibitor.

In the United States, the FDA approved cemiplimab for patients with CSCC in September 2018.

References

  1. Migden MR, Khushalani NI, Chang ALS, et al. Primary analysis of phase 2 results of cemiplimab, a human monoclonal anti–PD-1, in patients (pts) with locally advanced cutaneous squamous cell carcinoma (laCSCC). J Clin Oncol. 2019;37(suppl 15;abstr 6015).
  2. Guminski AD, Lim AML, Khushalani NI, et al. Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12-month follow-up. J Clin Oncol. 2019;37(suppl 15;abstr 9526).

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