What is the role of sonidegib in the management of basal cell carcinoma (BCC)?

Updated: Mar 23, 2021
  • Author: Robert S Bader, MD; Chief Editor: William D James, MD  more...
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A second Hedgehog pathway inhibitor (HHI), sonidegib (Odomzo), was approved by the FDA in 2015. Approval was based on the BOLT trial in patients had locally advanced BCC not amenable to curative surgery or radiation or metastatic basal cell carcinoma. Patients were randomized in a 1:2 ratio to receive 200 mg or 800 mg oral sonidegib daily, stratified by disease, histological subtype, and geographical region. For the 66 patients in the 200 mg group, the overall response rate was 58%; 3 patients (5%) achieved a complete response and 35 (53%) achieved a partial response. The duration of response ranged from 1.9 to 18.6 months, and in approximately half of the responding patients, the tumor shrinkage lasted at least 6 months. [101]

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