Odomzo - Sonidegib

What is Odomzo - Sonidegib used for and what is it used for?

Odomzo is an anticancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) that is locally advanced (ie that has begun to spread in adjacent areas) and that cannot be treated with surgery or radiotherapy (radiation treatment). ).

Odomzo contains the active ingredient sonidegib.

How is Odomzo - Sonidegib used?

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 its supervision.

Odomzo is available as capsules (200 mg) and the recommended dose is one capsule 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 a benefit is observed or until the medicine can no longer be taken because of its side effects.

For more information, see the package leaflet.

How does Odomzo - Sonidegib work?

Some tumors, including basal cell carcinoma, develop following the hyperactivity of a specific set of cellular processes called the Hedgehog signaling pathway. This pathway usually controls a series of cellular activities, including cell growth and the correct modalities of cellular development in the construction of various organs in unborn children. 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 the growth and spread of cancer cells.

What benefit has Odomzo - Sonidegib shown during the studies?

Odomzo has been studied in a main study involving 230 patients with locally advanced or metastatic basal cell carcinoma (spread to other parts of the body). The therapy started with two different doses of Odomzo: 200 or 800 mg once a day. The main measure of effectiveness was the response to treatment, determined based on a reduction in the tumor mass and the improvement of 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 patients treated with the 200 mg dose responded to treatment and 45% (58 of 128 patients) of subjects treated with the 800 mg dose . Response rates were less than 20% in patients with metastatic cancer treated with 200 or 800 mg of Odomzo. For this reason, the company withdrew the 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 of Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste changes, fatigue, nausea, vomiting, muscle and bone pain, stomach ache, headache, diarrhea, drop weight, loss of appetite and itching. For the full list of all side effects reported with Odomzo, see the package leaflet.

Odomzo cannot be used in pregnant or lactating women. The medicine should not be taken by women of childbearing age, unless they adhere to Odomzo's pregnancy prevention program. For the full list of limitations, 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 the benefits of Odomzo had been demonstrated in patients with locally advanced carcinoma. He also considered 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 included in the summary of product characteristics and the package leaflet for Odomzo, including the appropriate precautions to be followed by healthcare professionals and patients.

Furthermore, the company will send a letter to the doctors when Odomzo is launched. It will also provide information material to doctors and patients, including a reminder of the risks of the medicine and, in particular, the risk of serious damage to the unborn child if Odomzo is taken during pregnancy. Substances that interfere with the Hedgehog pathway can cause serious damage to the unborn child. Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after the end of therapy. Men treated with Odomzo must always use a condom in sexual relations with female partners and for 6 months after the end of therapy.

In addition, the company must provide a further analysis based on its main study on the efficacy and safety of Odomzo, including the effectiveness of the medicine in fast-growing and slow-growing basal cell carcinomas. The company is also required to analyze the tumor material taken from patients in which the carcinoma has worsened despite the treatment, to determine the reasons for the failure of the therapy.

Further information is available in the summary of the risk management plan.