The drug sonidegib (trade name: Odomzo) has been approved in Germany since February 2018 for adults with locally advanced basal cell carcinoma.
Basal cell carcinoma (basal cell cancer, basalioma), a type of non-melanoma skin cancer, is the most common type of skin cancer. In most cases it develops on the face, the nape of the neck or other parts of the head that are regularly exposed to sun. It is more common in older people. When basal cell carcinoma is discovered, it is usually removed completely in surgery. But sometimes the tumor has already become too big. Radiotherapy is then an option. Sonidegib can be used in patients with basal cell carcinoma who can't have surgery or radiotherapy.
The drug aims to inhibit tumor growth, preventing the disease from progressing.
Sonidegib is taken once daily at the same time in the form of a capsule (200 mg) at least two hours after and at least one hour before a meal. The dosage can be adjusted if side effects occur. This treatment is stopped if severe side effects occur or if the condition gets worse despite treatment.
The standard treatment for people with locally advanced basal cell carcinoma that can't be surgically removed or treated with radiotherapy is the drug vismodegib. Best supportive care (BSC) can also be used. It should be tailored to the patient's individual needs, relieve symptoms such as pain, and improve quality of life.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of sonidegib compared with the standard treatments for adults with advanced basal cell carcinoma.
But the manufacturer did not provide any suitable data with which to do the assessment.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of sonidegib (Odomzo).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Sonidegib (basal cell carcinoma) – Benefit assessment according to § 35a Social Code Book V. Dossier assessment; Commission A18-10. May 09, 2018. (IQWiG reports; Volume 624).
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