A new drug Odomzo (sonidegib) has received US Food and Drug Administration’s approval for treatment of locally advanced basal cell carcinoma that has recurred either following a surgery or radiation therapy, or for those patients who are not candidates for surgery or radiation therapy.
Basal cell carcinoma is one of the most common forms of skin cancer accounting for a whopping 80 per cent of non-melanoma skin cancers. The cancer starts developing in the top layer of the skin (called the epidermis) and mostly develops in areas regularly exposed to the sun and other forms of ultraviolet radiation. The term locally advanced basal cell skin cancer refers to basal cancers that have not spread to other parts of the body, but cannot be curatively treated with local treatments, specifically surgery and radiation.
Odomzo comes as a pill that has to be taken daily. The pill effectively inhibits a molecular pathway dubbed the Hedgehog pathway, which is active in basal cell cancers. Odomzo may stop or reduce the growth of cancerous lesions, by suppressing this pathway.
Though the drug has proven its efficacy, Odomzo does come with a set of its own side effects. One thing that healthcare professionals and patients need to be aware about is the boxed Warning alerting that Odomzo may cause death or severe birth defects in a developing fetus when administered to a pregnant woman. Pregnancy status should be verified prior to the start of Odomzo treatment, and both male and female patients should be warned about these risks and advised to use effective contraception.
During the double-blind clinical trial, 66 patients with locally advanced basal cell carcinoma were randomly assigned to receive Odomzo 200 mg daily and 128 patients were assigned to receive Odomzo 800 mg daily.
The study’s primary endpoint was objective response rate, which is the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s).
Results showed that 58 per cent of patients treated with Odomzo 200 mg had their tumors shrink or disappear. This effect lasted at least 1.9 to 18.6 months, and approximately half of the responding patients’ tumor shrinkage lasted six months or longer. Response rates were similar in patients who received Odomzo 800 mg daily, however side effects were more common at this dose.
At a dose of 200 mg daily, the most common side effects of Odomzo were muscle spasms, alopecia (hair loss), dysgeusia (distortion in the sense of taste), fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia (muscle pain), abdominal pain, headache, pain, vomiting and pruritus (itching). Odomzo also has the potential to cause serious musculoskeletal-related side effects, including increased serum creatine kinase levels [with rare reports of muscle tissue breakdown (rhabdomyolysis)], muscle spasms, and myalgia.
Odomzo is marketed by East Hanover, New Jersey-based Novartis Pharmaceuticals Corporation. Erivedge is marketed by Genentech in San Francisco, California.
