Issue 30 - Jul 28, 2017
  • Pediatric MATCH starts to accrue children with recurrent and refractory cancers

    NCI and the Children’s Oncology Group opened enrollment in Pediatric Molecular Analysis for Therapy Choice—Pediatric MATCH—a long-awaited precision medicine trial.

    Pediatric MATCH, a series of single-arm phase II trials, will seek to screen between 200 and 300 patients per year, with the goal of screening 1,000 patients over four years, assigning children to therapies that target genomic characteristics of their diseases.

  • Conversation with The Cancer Letter

    Will Parsons: This is a fantastic opportunity to test precision oncology for pediatric patients in a large-scale way

    Though NCI-MATCH and Pediatric MATCH are similar in structure, they represent different approaches to oncology.

    While a small minority of adult cancer patients in the U.S. get treated on-protocol, in pediatric oncology only a small proportion of patients receive care off-protocol. Altogether 90 percent of childhood cancer patients are treated at institutions that are part of Children’s Oncology Group.

  • Conversation with The Cancer Letter

    Rita Redberg: FDA proposal to delay reporting of device malfunctions “should be tossed”

    A recent proposal to delay reporting of device malfunctions to FDA will weaken the already inadequate medical device reporting system at the agency, said Rita Redberg, a professor of medicine and cardiologist at the University of California San Francisco.

    Redberg, editor of JAMA Internal Medicine, has been studying adverse event reporting and medical device surveillance issues for over a decade. She often opines on recommendations of U.S. Preventive Services Task Force, and in 2014, as chair of an advisory committee for the Centers for Medicare and Medicaid Services, Redberg presided over the panel that expressed low confidence in low-dose CT screening for lung cancer (The Cancer Letter, May 9, 2014).

  • In Brief

    • Carlos Arteaga to head UT Southwestern Simmons Comprehensive Cancer Center
    • Larry Copeland appointed president of GOG Foundation
    • Edith Mitchell receives 2017 ASTRO Honorary Membership
    • SU2C-Lustgarten Foundation team aims to apply CAR T-cell therapy to pancreatic cancer
    • Andrew Baschnagel wins UW Carbone Cancer Center award for lung cancer study
    • Cancer groups release statement on health disparities research
    • Report shows cancer patients struggle to afford treatment
    • Christiana Care Gene Editing Institute, NovellusDx form personalized medicine partnership
  • Drugs and Targets

    • FDA expands approval of Yervoy to include pediatric patients 12 years and older with unresectable or metastatic melanoma
    • FDA accepts BMS applications for Opdivo four-week dosing schedule across approved indications
    • Novartis receives positive CHMP opinion for Rydapt for newly diagnosed FLT3-mutated AML, three types of advanced systemic mastocytosis
    • AstraZeneca and Merck from oncology collaboration
    • CHMP issues positive opinion for avelumab for metastatic Merkel cell carcinoma
Issue 29 - Jul 21, 2017
Issue 28 - Jul 14, 2017
  • 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