Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation
Summary
As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. In exchange for a speedy approval based on less data, Novartis (NYSE: NVS) will likely need to conduct additional studies to confirm the drug’s benefit to patients. The regulator on Wednesday also approved a companion diagnostic from Foundation Medicine that tests for the genetic mutation that leads to MET exon 14 skipping. The most common side effects reported from the study included leg swelling, nausea, fatigue, vomiting, shortness of breath, and decreased appetite.