publication date: Jul. 14, 2017
Issue 28 - Jul. 14, 2017
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  • ODAC unanimously recommends approval for CAR T-cell therapy for relapsed and refractory B-cell ALL in kids and young adults

    “If you want to see what a cure looks like, you already have,” said Tom Whitehead as his daughter Emily joined him at the lectern at the public hearing of the FDA Oncologic Drugs Advisory Committee July 12.

    “She’s standing right beside me.”

  • Removed from U.S. market in 2011, Pfizer’s Mylotarg slated to return following results of a French study that tested a new regimen

    The FDA Oncologic Drugs Advisory Committee July 11 voted to approve Pfizer’s Mylotarg (gemtuzumab ozogamicin, GO), a CD33-directed antibody-drug conjugate for the indication of “combination therapy with daunorubicin and cytarabine for the treatment of adult patients with previously untreated, de novo CD33-positive acute myeloid leukemia.

    The committee voted 6-1 in favor of approval.

  • FY18 health budget battle begins: House appropriators slate $1.1 billion increase for NIH while defunding ACA, Title X

    The House Subcommittee on Appropriations for Labor-HHS marked up the fiscal 2018 spending bill—voting 9-6 along party lines on legislation that would prohibit the use of any new discretionary funding in connection with the Affordable Care Act.

    The bill includes $156 billion in discretionary spending, which is $5 billion below the fiscal 2017 enacted level. Nevertheless, this amount is $5 billion above the fiscal 2018 sequestration cap enacted under the Budget Control Act of 2011. The sequester will automatically activate unless a deal—much like the Bipartisan Budget Act of 2013 achieved by Rep. Paul Ryan (R-WI) and Sen. Patty Murray (D-WA)—is reached.

  • In Brief

    • Steven Piantadosi steps down at Cedars-Sinai to focus on clinical trial design
    • Edus Warren named leader of Fred Hutch Global Oncology program
    • Interdisciplinary program at NYU Langone targets pancreatic cancer
    • Fox Chase Cancer Center creates a fellowship
  • Drugs and Targets

    • FDA converts accelerated approval of Amgen’s Blincyto to full approval in ALL
    • FDA places clinical hold on Merck’s three Keytruda multiple myeloma studies

Copyright (c) 2017 The Cancer Letter Inc.