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May 1, 2014, Thursday, 03:32 GMT | 22:32 EST | 08:02 IST | 10:32 SGT
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For patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC), a breakthrough therapy drug could bring treatment. Accelerated approval for a breakthrough therapy designation, priority review and orphan product designation was announced on Tuesday for Zykadia (ceritinib), four months ahead of review completion goal date, by the U.S. Food and Drug Administration. The FDA was scheduled to complete review of the drug application on August 24, 2014, the product’s prescription drug user fee goal date. Zykadia is marketed by Novartis AG (NVS-NYSE) based in East Hanover, N.J.

Lung cancer is the leading cause of cancer-related deaths among women and men. According to the National Cancer Institute, an estimated 224,210 Americans will be diagnosed with lung cancer with 159,260 who will die from the disease during 2014. The most common type of lung cancer is NSCLC which makes up 85% of all lung cancers. Of patients with NSCLC, only 2% to 7% are ALK-positive.

Through preliminary clinical evidence, the sponsor demonstrated that Zykadia may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted to be a significant improvement in safety or effectiveness in the treatment of a serious condition and the drug is intended to treat a rare disease, respectively. Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said, “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. 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.”

Under the FDA’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, Zykadia is approved. While the manufacturer conducts confirmatory clinical trials, the accelerated approval program provides earlier patient access to promising new drugs.

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.

The safety and effectiveness of treatment with Zykadia were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. Results of the treatment showed that nearly half of the participants showed signs that their tumors had shrunk, with the effect lasting 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.