Sonidegib, a hedgehog pathway inhibitor, was approved by the US FDA for the treatment of locally advanced basal cell carcinoma which cannot be readily treated with surgery or radiotherapy. The pharmacology and pharmacokinetics of sonidegib will be discussed in this review. Additionally, an in-depth analysis of the BOLT trial and data from the 30-month update will be included. This will serve as an update to a previously published article which reported the 12-month update of the BOLT trial.
BackgroundBasal cell carcinoma (BCC) is the most common skin cancer in humans. Annually, there are 2.8 million cases that result in approximately 3000 deaths [1]. The use of surgical excision for the treatment of BCC results in a 5-year cure rate close to 90% [2,3]. The 5-year recurrence rate decreases to 0.7-2.4% when Mohs micrographic surgery (MMS) is performed [4][5][6][7]. Alternative nonsurgical approaches include cryotherapy, electrodesiccation and curettage, photodynamic therapy, radiation, or topical agents such as imiquimod or 5-fluorouracil. These options usually confer a lower cure rate and lack confirmation of tumor clearance on histology. Although metastasis of BCC has a very low incidence of 0.0028-0.