FDA OKs Novartis’ Skin Cancer Drug
The US Food and Drug Administration has approved Novartis’ Odomzo (sonidegib) 200-mg capsules for treating 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. SMO is a molecule that regulates the hedgehog (Hh) signaling pathway, which plays a role in stem-cell maintenance and tissue repair, as well as in advanced basal cell carcinoma. Odomzo is currently in clinical development in other diseases.
Odomzo was approved in Switzerland for treating advanced BCC that is not amenable to curative surgery or radiotherapy on June 30, 2015. The European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion on June 25, 2015. Additional regulatory submissions are being reviewed by health authorities worldwide.