The FDA has designated Novartis’s anticancer drug LDK378 as a "breakthrough therapy," thereby placing it on a faster track for FDA approval. Breakthrough therapy is a status reserved for drugs that treat serious conditions and that have been shown by preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).