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FDA Approves Cemiplimab-Rwlc for laBCC, mBCC

On February 9, 2021, the FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals), a PD-1 blocking antibody, for the treatment of patients with locally advanced basal cell carcinoma (laBCC) and has metastatic BCC (mBCC).

The efficacy of cemiplimab-rwlc was evaluated in Study 1620, which enrolled patients with advanced BBC (laBCC: n = 84; mBCC: n = 28) that progressed with hedgehog pathway inhibitor (HHI) therapy, had no objective response after 9 months of HHI therapy, or who were intolerant of HHI therapy. Eligibility required that laBCC patients not be candidates for curative surgery or radiotherapy.

Patients with laBCC had an overall response rate (ORR) of 29% (95% CI, 19-40) and the median duration of response (DOR) was not reached. Approximately 80% of patients maintained their response for at least 6 months.

Among patients with mBCC, confirmed ORR was 21% (95% CI, 8-41) with a median DOR not reached; all responders maintained their responses for at least 6 months.

Severe adverse events associated with cemiplimab-rwlc include immune-mediated adverse reactions (eg, pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and infusion reactions. The most common (≥20%) adverse reactions reported were fatigue, musculoskeletal pain, diarrhea, rash, and pruritis.—Emily Bader

Source: US Food and Drug Administration. FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma. February 9, 2021. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-locally-advanced-and-metastatic-basal-cell-carcinoma. Accessed February 10, 2021.

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