The FDA has granted approval to Zykadia (ceritinib) to treat patients with late-stage (metastatic) non-small cell lung cancer (NSCLC). Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor. Zykadia is marketed by Novartis.
Lung cancer is the leading cause of cancer-related deaths in the US. According to the National Cancer Institute, an estimated 224,210 men and women in the US will be diagnosed with lung cancer, and 159,260 will die from the disease this year. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. However, only 2-7 percent of patients with NSCLC are ALK-positive.
The FDA is approving Zykadia under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Results of Zykadia's clinical trials showed that about half of the 163 participants had their tumors shrink, and this effect lasted an average of about seven months.
Common side effects of Zykadia include gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain. Laboratory abnormalities such as increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed.
[1] FDA News Release, "FDA approves Zykadia for late-stage lung cancer," April 29, 2014.
Lung cancer is the leading cause of cancer-related deaths in the US. According to the National Cancer Institute, an estimated 224,210 men and women in the US will be diagnosed with lung cancer, and 159,260 will die from the disease this year. About 85 percent of lung cancers are NSCLC, making it the most common type of lung cancer. However, only 2-7 percent of patients with NSCLC are ALK-positive.
The FDA is approving Zykadia under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Results of Zykadia's clinical trials showed that about half of the 163 participants had their tumors shrink, and this effect lasted an average of about seven months.
Common side effects of Zykadia include gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain. Laboratory abnormalities such as increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed.
[1] FDA News Release, "FDA approves Zykadia for late-stage lung cancer," April 29, 2014.
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