Odomzo (sonidegib)

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Odomzo (sonidegib)

How to buy Odomzo: You can order Odomzo (sonidegib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Eli Lilly and Co.
Disease Skin Cancer
Indication Locally advanced basal cell carcinoma
Mode of Action Hedgehog pathway inhibitor
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
Strength 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 [1][2][3].

Recommended dose

Complete information about Odomzo (sonidegib) dosage and administration can be found here: [3][4][2].
The standard dosage is:
  • One 200 mg capsule once a day at least 1 hour before and 2 hours after a meal.
Consult your treating doctor for personalised dosing.

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 [3][4].
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 [1].
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 [1].

What is sonidegibf's approval status?

Odomzo (sonidegib) was approved by:
  • FDA (USA) on July 24, 2015 [3]
  • EMA (EU) on August 14, 2015 [1]
  • TGA (AUS) on December 19, 2016 [2]
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) [4] on the 800 mg dose [1]. 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 [4].
References
[1] EMA. Human Medicines: Odomzo (sonidegib), 02/09/2015 (last update: 06/06/2017), cited on 22/05/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002839/human_med_001897.jsp&mid=WC0b01ac058001d124
[2] TGA. Public Summary. Odomzo (sonidegib), 10/08/2015.
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=1FBD817B69A7DACACA25813000422329&agid=(PrintDetailsPublic)&actionid=1
[3] Summary of Product Characteristics [FDA]: Odomzo (sonidegib), Novartis Pharmaceuticals Corporation, Jul. 2015.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205266s000lbl.pdf
[4] Summary of Product Characteristics [EMA]: Odomzo (sonidegib), Sun Pharmaceutical Industries Europe B.V., Jun. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002839/WC500192970.pdf









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