FDA Gives Early Approval to Novartis Drug for Lung Cancer

FDA Gives Early Approval to Novartis Drug for Lung Cancer

A new drug for the treatment of non-small cell lung cancer has sought the approval from the US Food and Drug Administration (FDA) on Tuesday.

The Swiss pharmaceutical company Novartis AG announced that the approval from the FDA for the drug, ceritinib, which will be marketed under the brand name Zykadia, will help the company in early launch of the drug. The approval was expected to come by August 2014 and the earlier approval from the FDA panel has been appreciated by the company management.

The drug is developed to target lung cancer, which is the leading cause of cancer-related deaths in both men and women. As per estimates of the National Cancer Institute, nearly 225,000 Americans will be diagnosed with lung cancer this year. Almost 160,000 of them will succumb to the disease this year.

Zykadia is a tyrosine kinase inhibitor specific to anaplastic lymphoma kinase (ALK) and it acts as blocking agent for the proteins that spur the growth and development of cancer cells. The drug will only be prescribed to patients with metastatic ALK-positive non-small cell lung cancer who have not sought any improvement in their condition from a current ALK inhibitor called crizotinib.

Crizotinib is the only other drug used to target ALK tyrosine kinases. Zykadia has been designated as a breakthrough therapy by the FDA and that is the reason for FDA priority review status for the drug.

Novartis claim that the drug has high efficacy to offer substantial improvement over available therapies, along with 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.


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