Odomzo - Sonidegib
What is Odomzo - Sonidegib and what is it used for?
Odomzo is an anticancer medicine used to treat adults with locally advanced basal cell carcinoma (a type of skin cancer) (i.e. it has started to spread to adjacent areas) and cannot be treated with surgery or radiotherapy (radiation treatment ).
Odomzo contains the active substance sonidegib.
How is Odomzo used - Sonidegib?
Odomzo can only be obtained with a prescription. It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under his supervision.
Odomzo is available as capsules (200 mg) and the recommended dose is one capsule to be taken once a day, at least two hours after a meal and at least one "hour before the next meal. Treatment with Odomzo should be continued until you have observe a benefit or until the medicine can no longer be taken due to its side effects.
For more information, see the package leaflet.
How does Odomzo - Sonidegib work?
Some cancers, including basal cell carcinoma, develop as a result of the overactivity of a specific set of cellular processes called the Hedgehog signaling pathway. This pathway usually controls a range of cellular activities, including cell growth and proper cell development patterns. in the construction of various organs in unborn babies. Sonidegib, the active ingredient in Odomzo, binds to a protein that controls the Hedgehog signaling pathway. By binding to this protein, sonidegib blocks the Hedgehog signaling pathway thereby reducing growth and the spread of cancer cells.
What benefit has Odomzo - Sonidegib shown during the studies?
Odomzo was studied in one main study involving 230 patients with locally advanced or metastatic basal cell carcinoma (spread to other parts of the body). Therapy started with two different doses of Odomzo: 200 or 800 mg once a day. The main measure of effectiveness was response to treatment, as determined by a reduction in tumor mass and improvement in other signs of the tumor; treatment would have been considered sufficiently effective if the objective response rate was at least 30%. .
In patients with locally advanced basal cell carcinoma, approximately 56% (37 of 66 patients) of subjects treated with the 200 mg dose and 45% (58 of 128 patients) of subjects treated with the 800 mg dose responded to treatment. . Response rates were less than 20% in patients with metastatic cancer treated with the 200 or 800 mg dose of Odomzo. For this reason, the company withdrew its marketing authorization application for the use of Odomzo in the treatment of metastatic basal cell carcinoma.
What is the risk associated with Odomzo - Sonidegib?
The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, abdominal pain, headache, diarrhea, weight loss, loss of appetite and itching sensation. For the full list of side effects reported with Odomzo, see the package leaflet.
Odomzo cannot be used in pregnant or breastfeeding women. The medicine should not be taken by women of childbearing potential unless they adhere to the Odomzo pregnancy prevention program. For the full list of restrictions, see the package leaflet.
Why has Odomzo - Sonidegib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Odomzo's benefits were demonstrated in patients with locally advanced cancer, and he also felt that the side effects were manageable.
What measures are being taken to ensure the safe and effective use of Odomzo - Sonidegib?
A risk management plan has been developed to ensure that Odomzo is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Odomzo, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company will send a letter to doctors when Odomzo is launched. It will also provide information material to doctors and patients, including a reminder on the risks of the medicine and, in particular, on the risk of serious harm to the unborn child if Odomzo is taken during pregnancy. Substances that interfere with the Hedgehog pathway can cause serious harm to the unborn child. Therefore, women taking Odomzo must take effective measures to prevent pregnancy during the course of treatment and for 20 months after the end of therapy. Men being treated with Odomzo should always use a condom during sexual intercourse with female partners and for 6 months after the end of therapy.
In addition, the company is to provide an additional analysis based on its main study on the efficacy and safety of Odomzo, including the efficacy of the medicine in fast-growing and slow-growing basal cell carcinomas. The company is also required to analyze the material. taken from patients whose cancer has worsened despite treatment, to determine the reasons for therapy failure.
Further information can be found in the summary of the risk management plan.
Other information about Odomzo - Sonidegib
For more information about Odomzo therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
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