The U.S. FDA has approved Odomzo® (sonidegib, formerly LDE225) for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.  Odomzo is an oral, selective smoothened (SMO) inhibitor developed and marketed by global pharmaceutical giant, Novartis Pharmaceuticals Corporation.  Skin cancer is the most common cancer and BCC accounts for approximately 80 percent of non-melanoma skin cancers.   Scientific research has shown that SMO, an important component in the hedgehog signaling pathway, plays a critical role in advanced BCC.  This approval is based on data from the Phase II, randomized, double-blind multicenter BOLT trial which demonstrated a durable objective response rate in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma.

 

Original Article:

https://www.novartis.com/news/media-releases/fda-approves-novartis-drug-odomzo%C2%AE-sonidegib-locally-advanced-basal-cell