|| Eli Lilly and Co.
|| Skin Cancer
|| Locally advanced basal cell carcinoma
| Mode of Action
|| Hedgehog pathway inhibitor
| Approval Status
|| EMA approved (EU); FDA approved (USA); TGA approved (AUS)
|| 200 mg
Who is sonidegib for?
Odomzo (sonidegib) is indicated for the treatment of patients with basal cell carcinoma which is locally advanced and which cannot be treated either by surgery or by radiotherapy .
Complete information about Odomzo (sonidegib) dosage and administration can be found here: 
The standard dosage is:
Consult your treating doctor for personalised dosing.
- One 200 mg capsule once a day at least 1 hour before and 2 hours after a meal.
What is sonidegib and how does it work?
Odomzo is a Hedgehog pathway inhibitor used to treat adults with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy .The Hedgehog signaling pathway is a set of processes that control a number of cell activities including cell growth and correct development and differentiation. The active ingredient in Odomzo, sonidegib, attaches to a protein that controls the Hedgehog signaling pathway. By attaching to this protein, sonidegib blocks the Hedgehog signaling pathway and thereby reduces the growth and spread of cancer cells .
The most common side effects are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching. Women who are pregnant or who are breastfeeding must not take Odomzo 
What is sonidegibf's approval status?
Odomzo (sonidegib) was approved by:
for the treatment of adults with locally advanced basal cell carcinoma (BCC) that cannot be treated with surgery or radiation therapy.The approvals of Odomzo (sonidegib) for locally advanced BCC were based on one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic. Patients were started on two different doses of sonidegib: 200 or 800 mg once a day. The response on metastatic BCC was less than 20 %. However, the medicine resulted effective on patients with locally advanced BCC with a response rate of 56 % (95 % CI: 43.3, 68.3) on the 200 mg dose, with 5 % complete responses, and 45 % (95 % CI: 43.3, 68.3)  on the 800 mg dose . On the 200 mg dosage, the time to tumour response was 4.0 months (95 % CI: 3.8, 5.6) and the median duration of response was 26.1 months .
- FDA (USA) on July 24, 2015 
- EMA (EU) on August 14, 2015 
- TGA (AUS) on December 19, 2016 
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.