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FDA Approves Novartis Drug To Treat Non-small Cell Lung Cancer

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The U.S. Food and Drug Administration has approved Novartis AG's drug to treat patients with non-small cell lung cancer.

Tabrecta has been approved for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations.

The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for Tabrecta.

"Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.

"Tabrecta is the first approval specifically for the treatment of patients with non-small cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they didn't have prior to today."

NSCLC is a disease in which malignant cancer cells form in the tissues of the lung. It is the most common type of lung cancer with up to 90% of all lung carcinomas falling into the non-small cell category. NSCLC occurs when healthy cells become abnormal and grow rapidly.

Novartis had licensed Tabrecta from Incyte Corp in 2009. The drug got a priority review from the FDA in February.

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