2013 Breakthrough Therapies Designation Year-End Update | Friends of Cancer Research

You are here

2013 Breakthrough Therapies Designation Year-End Update

  
2013 Breakthrough Therapies Designation Year-End Update 
 
Designations Granted by the FDA: 37 
 
Requests Denied by the FDA: 70 
 
Designations Announced Publicly by Companies: 28 
  • Cancer: 12 
  • Hepatitis C: 4 
  • Cystic Fibrosis: 2 
  • Autoimmune Disorders: 2
    • (Lambert Eaton Myasthenic Syndrome) 
    • (Sporadic inclusion body myositis) 
  • Heart Disease: 1 
  • Malaria: 1 
  • Antidote for Factor XA Inhibitors: 1 
  • Molybdenum cofactor deficiency: 1 
  • Duchenne muscular dystrophy: 1 
  • Hypophosphatasia: 1 
  • Lysosmomal acid lipase deficiency: 1 
  • Epidermolysis bullosa: 1 
Approvals: 3 
  • Gazyva (obinutuzumab) - (Genetech/Roche) – Approved 11/1/2013 for chronic lymphocytic leukemia (CLL) 
  • Ibrutinib - (J&J/Pharmacyclics) – Approved 11/13/13 for mantle cell lymphoma 
  • Sofosbuvir/ledipasvir combination - (Gilead) – Approved 12/6/13 for Hepatitis C