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PART 1: FIRST-IN-CLASS AGENTS, BREAKTHROUGH THERAPIES, ORPHAN INDICATIONS, TESTS, AND NOVEL DEVICES

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In 2016 the U.S. Food and Drug Administration (FDA) approved 22 new drugs and granted 32 noteworthy biologic licenses. Among the 22 new drugs are:

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  • Six pharmacological "firsts" (Table P1-1);

  • Three diagnostic imaging agents for use with PET scans (fluciclovine F-18,1 gallium Ga-68 dotatate,2 and rubidium chloride Rb-82)3;

  • Three previously unapproved marketed drugs (see Part 2);

  • Two entities previously regulated only as a dietary supplements (see Part 2); and

  • Eight additional new molecular entities that are pharmacologically similar to previously approved drugs (see Part 2).

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The 32 noteworthy biologics approved in 2016 are described in Part 3 of this series. Among them are:

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  • 12 new authorizations expanding the clinical uses for biologics that are already on the market in the United States (see Tables P1-2 and P1-3);

  • Six first-to-market monoclonal antibodies;

  • Three biosimilars;

  • Three recombinant coagulation factors;

  • Three new influenza vaccines;

  • One new oral vaccine for travelers (cholera);

  • One previously marketed biologic approved for a new indication (daclizumab for multiple sclerosis);

  • A new immune globulin concentrate formulated for subcutaneous administration (notable for being the 12th SC IgG formulation to be marketed in the United States);

  • A new fibrin patch; and

  • A cellular sheet of chondrocytes for autologous implantation (MACI).

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In 2016 FDA authorized 19 new cancer therapies,4 approved 39 therapies for rare (orphan) conditions,5 and designated 16 drugs as therapy breakthroughs.6,7 Throughout this series, orphan, breakthrough, and cancer therapy designations are notated by the symbols †, $, and #, respectively, and biologics are notated by the symbol ¶. Table P1-2 lists the 15 marketed drugs and biologics that gained supplemental approval for an orphan indication in 2016. Among the breakthrough therapy drug approvals are two first-in-class small molecule drugs (pimavanserin, a selective serotonin 5-HT2A receptor reverse agonist, and venetoclax#, a B-cell lymphoma-2 [BCL-2] protein inhibitor) (Table P1-1); nine established drugs designated as breakthrough therapies for 13 serious disease states (Table P1-3); and two new monoclonal antibodies (atezolizumab# and olaratumab#) for cancer (see Part 3). Established in 2012, breakthrough designations are reserved for drugs exhibiting superior efficacy against serious diseases.8 In the first four years of the program, a total of 59 breakthrough therapies were approved.9

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Companion diagnostic tests were licensed in 2016 in conjunction with FDA approval of venetoclax# (see Table P1-1) and rucaparib# (see Part 2). In 2016, a third test was licensed to help detect the subset of patients with metastatic non-small cell lung cancer who qualify as candidates for therapy with erlotinib# (Tarceva)10-11 and a fourth new test (Xpert Carba-R Assay) was licensed as an infection control aid for the in-house detection of genetic markers associated with carbapenem antibiotic resistance.12...

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