Sonidegib (Odomzo)
General information
Class/mechanism: Hedgehog pathway inhibitor. Sonidegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.[1][2]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established
Patient drug information
History of changes in FDA indication
- 2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy. (Based on BOLT)
- 2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who are not candidates for surgery or radiation therapy. (Based on BOLT)
History of changes in EMA indication
- 2015-08-14: Initial authorization
- Uncertain date: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
Also known as
- Code name: LDE-225
- Generic name: erismodegib
- Brand name: Odomzo