Novartis ($NVS) won accelerated approval for a promising oncology drug, gearing up to launch a new treatment for an advanced form of the most common type of skin cancer.
The drug, sonidegib, is an oral treatment that targets the body's hedgehog pathway to block tumor growth and treat basal cell carcinoma (BCC), which accounts for more than 80% of nonmelanoma dermal cancers and affects nearly 3 million Americans each year, according to the Skin Cancer Foundation.
|Novartis Oncology President Bruno Strigini|
Novartis convinced the FDA with data from a Phase II trial in which 58% of patients taking sonidegib saw their tumors either shrink or disappear entirely. The treatment, to be marketed as Odomzo, is approved for patients whose BCC has returned despite surgery or radiation therapy.
"The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring," Novartis Oncology President Bruno Strigini said in a statement. "Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients."
The drug, also in development for brain cancer and solid tumors, is among 10 pipeline treatments and new indications Novartis' ambitious oncology division expects to launch by 2017.
- read the statement