FDA Approves New Drug Zykadia to Treat Lung Cancer

Novartis's new therapy drug 'Zykadia' received a nod from the U.S. health regulators to treat late stage lung cancer.

The U.S. Food and Drug Administration has approved Zykadia (ceritinib) for those with a certain type of late stag non-small cell lung cancer (NSCLC).  The newly approve drug is the fourth drug with breakthrough designation to win FDA approval.  This drug won approval four months prior to the  goal date of Aug 24, 2014, when the agency was expected to finish reviewing the drug application.

Zykadia (ceritinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor. This drug is known to a play a crucial role by blocking the proteins that boost the development of cancerous cells. The health regulators caution that the drug is strictly meant for those with ALK metastatic ALK-positive NSCLC and who were earlier treated with drug Crizotinib, the only approved treatment for the cancer till date.

"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," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

One of the leading causes of cancer related deaths is lung cancer. It is known to affect both men and women. Statistic according to the National cancer Institute reveal that this year nearly 224,210 Americans will be diagnosed with lung Cancer and 159,260 will die from the disease. Nearly 85 percent of the lung cancers are NSCLC due to which it is marked as the most common type of lung cancer.  A small 2-7 percent of those with NSCLC are ALK-positive.

Apart from the breakthrough therapy designation, the drug also received priority review and orphan designation because the drug offers substantial improvement over other existing therapies.

The drug was approved under the accelerated approval program that permits green signaling a drug to treat serious or life-threatening conditions. 

The safety and effectiveness was tested in a clinical trial that included 163 patients with metastatic ALK-positive NSCLA. All of them were treated with Zykadia.  The researchers noticed that tumors in half of the patients shrank and the effect lasted on an average of seven months.

Common side effects noticed include gastrointestinal symptoms such as nausea, vomiting, diarrhea and abdominal pain. Other laboratory abnormalities noticed included increased liver enzymes, pancreatic enzymes and increased glucose levels.