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The FDA in the USA granted regular approval to cemiplimab-rwlc (Libtayo(R)) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate. The fully human monoclonal antibody targeting PD-1 is approved at the recommended dose of 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. Severe adverse reactions are immune-mediated adverse reactions (e.g. pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus and nephritis) and infusion reactions. The most common adverse reactions (incidence ≥ 20%) were fatigue, musculoskeletal pain, diarrhea, rash, and pruritus.