EC OKs Novartis’ Skin Cancer Drug
The European Commission has approved Novartis’ Odomzo (sonidegib) 200 mg capsules for treating adult patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy.
The European Union (EU) approval follows a positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2015 and applies to all 28 EU member states, plus Iceland, Norway, and Liechtenstein. Outside the EU, Odomzo is approved in the United States, Australia, and Switzerland. Additional regulatory submissions are being reviewed by health authorities worldwide.
Odomzo is an oral, selective smoothened inhibitor (SMO). SMO is a molecule that regulates the hedgehog 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.