Novartis gets FDA approval for Odomzo

SILVER SPRING, Md. — The Food and Drug Administration announced Friday that it had approved Novartis’ Odomzo (sonidegib). The drug is meant to treat basal cell carcinoma, the most common form of advanced skin cancer, in patients who are not candidates for surgery or radiation therapy, or whose cancer has recurred following treatment. 

 

“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,” Bruno Strigini, President, Novartis Oncology, said. "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 approval of Odomzo is another step for new treatments for cancer based on increased research, the FDA said. 

 

“Our increasing understanding of molecular pathways involved in cancer has led to approvals of many oncology drugs in difficult-to-treat diseases for which few therapeutic options previously existed,”  Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said.