PART 1 FIRST-IN-CLASS AGENTS
The FDA approved 33 drugs and biologics of note in 2011. Most are pharmacologically similar to others already marketed (see part 2 of this series). Among the remainder are 18 "first-in-class" agents for acute coronary syndrome, angioedema, chronic obstructive pulmonary disease, congenital factor XIII deficiency, depression, head lice, hepatitis C infection, lupus, lymphoma, melanoma, myelofibrosis, prostate cancer, seizures, diagnosis of Parkinsonian syndromes, and vaccination of military personnel against adenovirus (see Table 71-1). Fourteen of the new drug approvals in 2011 were granted orphan drug status for rare diseases (see Table 71-1 and part 2 of this series). Two of the new drugs (crizotinib for non-small cell lung cancer (see part 2 of this series) and vemurafenib for melanoma) were approved in conjunction with diagnostic genetic tests and represent a breakthrough in the field of personalized medicine.1 In addition, one new approval, HEMACORD, is the first cord blood therapy approved in the US.2
Table 71-1.New Pharmacological Drug Classes Introduced in 2011 |Favorite Table|Download (.pdf) Table 71-1. New Pharmacological Drug Classes Introduced in 2011
|Pharmacologic Class ||First to be Marketed in the U.S. ||FDA Approved ||Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e Reference |
|17Î±-hydroxylase/C17,20-lyase (CYP17) inhibitor ||abiraterone (zytiga) ||prostate cancer ||Chapter 63. Natural Products in Cancer Chemotherapy: Hormones and Related Agents (also see monograph below) |
|adenovirus vaccine ||adenovirus type 4, 7 vaccine, live, oral ||active immunization of military personnel ||Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants |
|bradykinin B2 receptor antagonist ||icatibant (firazyr)* ||hereditary angioedema ||Chapter 32. Histamine, Bradykinin, and Their Antagonists: Kinin Receptor Antagonists |
|BRAF kinase inhibitor || |
(approved with a companion diagnostic test for the BRAF V600E gene mutation)
|melanoma || |
Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines
(also see Vemurafenib, a first in classserine-threonine protein kinase inhibitor for the treatment of malignant melanoma with activating BRAF mutations by Keith T. Flaherty [update in press] in Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12e)
|microtubule disrupting agent (CD30-directed antibody-drug conjugate) ||brentuximab vedotin (adcetris)* ||lymphomas ||Chapter 62. Targeted Therapies: Tyrosine Kinase Inhibitors, Monoclonal Antibodies, and Cytokines |
|stem cells ||hematopoietic progenitor cells, cord blood (hemacord) ||hematopoietic progenitor cell transplantation ||(see Stem Cell Transplantation in Harrison's Principles of Internal Medicine, 18e) |
|pediculicide ||spinosad (natroba) ||head lice infestation ||Chapter 65. Dermatological Pharmacology (also see monograph below) |
|Janus associated kinase (JAK 1 and 2) inhibitor ||ruxolitinib (jakafi)* ||myelofibrosis ||Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants |
|monoclonal antibody against soluble BLyS ||belimumab (benlysta) ||systemic lupus erythematosus ||Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants (also see monograph below) |
|monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4 (CTLA4 [CD154]) ||ipilimumab (yervoy)* ||melanoma || |
Chapter 35. Immunosuppressants, Tolerogens, and Immunostimulants
(also see Ipilimumab: A New Therapeutic Option for Metastatic Melanoma by Jamie Poust (update 11/11/2011) in Pharmacotherapy: A Pathophysiologic Approach, 8e)
|NS3/4A protease inhibitor ||boceprevir (victrelis) ||hepatitis C infection ||Chapter 58. Antiviral ...|
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