The new Novartis drug Zykadia was approved by the FDA in an early decision and will be used for the treatment of a specific type of non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) announced Tuesday that it had approved a new drug for the treatment of non-small cell lung cancer. The drug, ceritinib, will be marketed under the brand name Zykadia by the Swiss pharmaceutical company Novartis AG. The approval came four months earlier than the anticipated FDA approval decision date.
Lung cancer is the leading cause of cancer-related deaths in both men and women. The National Cancer Institute estimates that almost a quarter of a million Americans will be diagnosed with lung cancer and of those, almost 160 million of them will die this year. Of these case, approximately 85% are non-small cell lung cancer cases. However, Zykadia will only be used to treat a small subset of these cases.
Zykadia is a tyrosine kinase inhibitor specific to anaplastic lymphoma kinase (ALK). It works by blocking the proteins that promote the growth and development of cancer cells. It will only be given to patients with metastatic ALK-positive non-small cell lung cancer who have already been treated with a current ALK inhibitor called crizotinib, the only other drug for targeting ALK tyrosine kinases.
The FDA designated Zykadia a breakthrough therapy, gave it priority review status, and categorized it as an orphan product, all of which account for the drug’s early approval. Novartis demonstrated that the drug offered substantial improvement in efficacy over available therapies as well as substantial improvement in safety in the treatment of a serious but rare disease.
“Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program.”