Zykadia (ceritinib) approved for late-stage lung cancer, Diplomat to distribute
Thursday, May 01, 2014
Diplomat has announced that it is a member of a limited panel of specialty pharmacies selected to distribute Zykadia (ceritinib), a newly approved breakthrough drug for the treatment of late-stage lung cancer. The U.S. Food and Drug Administration approved Zykadia on April 29, 2014, four months ahead of the product’s projected approval date, and is the fourth drug to receive approval under the breakthrough therapy designation. Zykadia is approved to treat anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib.
Zykadia is an anaplastic lymphoma kinase tyrosine kinase inhibitor that blocks proteins that promote cancerous cell development. In clinical trials, Zykadia was shown to reduce the size of tumors in about half of the participants. Zykadia was granted breakthrough designation, priority review and orphan product designation because the results from the trial demonstrated that the product offers significant improvement over products currently on the market, improves the safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease.
According to the National Cancer Institute, lung cancer is the leading cause of cancer-related deaths in the United States. While approximately 85 percent of lung cancer diagnoses are NSCLC, only 2-7 percent of those patients are ALK-positive. The FDA’s accelerated approval program is designed to provide patients with earlier access to promising new treatments for rare diagnoses, such as ALK-positive NSCLC.
Common side effects of Zykadia include gastrointestinal symptoms such as nausea, vomiting, abdominal pain and diarrhea. Increased liver and pancreatic enzymes as well as increased glucose levels were also observed. Zykadia is manufactured by Novartis. Full prescribing information for Zykadia is available at the manufacturer’s website.
Novartis Pharmaceuticals Corporation, a member of Novartis Group, is headquartered in East Hanover, New Jersey. The company researches, develops, manufactures and markets innovative medicines that aim to improve patients’ lives. Novartis offers medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions.
Diplomat serves patients and physicians in all 50 states as the nation’s largest independent specialty pharmacy. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with specialized, long-term medical needs, including cancer, HIV, hepatitis C, multiple sclerosis and many other serious or chronic conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues — always focused on increasing adherence and improving outcomes. Diplomat has accreditations from URAC, PCAB, VAWD, ASHP and ACHC. Learn more at diplomat.is.