The FDA labelled Roche�s $RHHBY Actemra/RoActemra (tocilizumab) a Breakthrough Therapy for the treatment of giant cell arteritis (GCA), a chronic potentially life-threatening autoimmune condition characterized by the inflammation of the large and medium-sized arteries. If a drug candidate receives as Breakthrough Therapy Status by the FDA then the company which is developing the treatment gets intensive guidance from the regulator�s review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).