The U.S. Food and Drug Administration (FDA) has given its approval to a new oral drug intended for a type of skin cancer known as "locally advanced basal cell carcinoma (BCC)," FDA official release stated.
The drug sonidegib (Odomzo) is given by mouth and it helps regulate the "hedgehog molecular pathway," which plays an important role in maintaining stem cells and repairing tissues and also in advanced basal cell cancers.
The once-a-day pill formulation is marketed by Swiss pharmaceutical behemoth, Novartis AG.
FDA noted that the pill is intended for use in patients who have locally advanced BCC that recurred following surgery or radiation therapy, or patients that are not candidates for these interventions.
Skin cancer is the most common type of cancer, as noted in the release, and roughly 80 percent of non-melanoma skin cancers are BCC.
BCC begins on the epidermis, the topmost layer of the skin and gradually spreads in areas that get regular sun exposure.
The approval from the drug regulators was based on successful clinical trials on 66 participants, randomly given different doses of Odomzo.
The drug trials showed that 58% of the participants who took Odomzo experienced partial or complete shrinkage of the tumors. According to the FDA, the drug's effect lasted for at least "1.9 to 18.6 months."
While that's a significant rate of success, the downside is that Odomzo packs several side effects. When given at 200mg daily, muscle spasms, hair loss, fatigue, nausea, decreased weight, and abdominal pain are just some of the many side effects reported.
Notably, 68% of the participants of the trial reported adverse musculoskeletal reactions, as stated in PharmaTimes.
The drug also carries a "boxed warning" stating that it may cause severe birth defects or even death of the developing fetus when given to pregnant women.
With Odomzo's approval, it becomes the second drug of its class, hedgehog pathway inhibitor, approved by the FDA, next to vismodegib (Erivedge) in 2012.
