FDA moves on breakthrough therapies

Two cystic fibrosis drugs have gained the first breakthrough therapy designation from the US Food and Drug Administration (FDA). In January, the agency announced that Vertexs Kalydeco (ivacaftor) alone and in combination with the experimental compound VX-809 would be the first to benefit from an expedited review process designed for potentially lifesaving drugs. In March, FDA added two oncology drugs to this pathway: the experimental lymphoma drug ibrutinib from Pharmacyclics of Sunnyvale, California, and the Novartis candidate drug LDK378 for treating lung cancer.