Novartis’ once-daily pill Odomzo has received European clearance for the most common type of skin cancer just weeks after being approved in the US.
The European Commission says the drug can be used to treat adult patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy.
BCC consists of abnormal, uncontrolled growths or lesions that arise in the skin's basal cells, which line the deepest layer of the epidermis. It accounts for more than80% of non-melanoma skin cancers, and its incidence globally is on the rise.
Odomzo (sonidegib) is an oral, selective smoothened inhibitor that regulates the hedgehog signalling pathway, known to play a critical role in stem cell maintenance and tissue repair as well as in advanced BCC.
EU approval of the drug was based on data from the Phase II BOLT study, in which 58% of patients responded to treatment. Median progression-free survival was 22 months in those taking the drug, Novartis said.
On the safety side, the most frequently reported adverse events included muscle spasms, alopecia, musculoskeletal pain and diarrhoea, but the most serious risks associated with drug are rhabdomyolysis and embryofetal toxicity.
According to Reinhard Dummer, MD, professor and vice chairman, Department of Dermatology at the University of Zurich, the approval of Odomzo brings new hope to patients “in the form of a non-invasive option to help treat this disfiguring and potentially life-threatening disease”.