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
Issue 27 - Jul 7, 2017
  • NCI-MATCH keeps enrolling—Targeted mutations are proving to be less common than estimated

    The NCI-MATCH trial has met its goal of screening 6,000 patients, but it will not stop there.

    The landmark precision medicine trial, which is essentially a collection of single-arm phase II studies, recently cleared four laboratories to identify patients who are getting tested as part of their care. If actionable mutations are found, these patients could become eligible for NCI-MATCH.

  • Conversation with The Cancer Letter

    Keith Flaherty: We will certainly stop if we enroll all subprotocols

    NCI and ECOG-ACRIN officials said the NCI-MATCH trial will keep going, continuing to match patients with treatment arms based primarily on their molecular characteristics.

    The institute will no longer pay for genotyping—which it has done to biopsy and genotype nearly 6,000 patients—but it will make use of genomic sequencing that’s being done by commercial labs and at some cancer centers to guide clinical care.

  • Conversation with The Cancer Letter

    Barbara Conley: Learning from first broad foray into precision medicine

    The first step in the NCI-MATCH trial—deciding how many patients to screen—was a guess.

    At first, NCI and ECOG-ACRIN thought genotyping 3,000 patients may be sufficient. Then the sample was upped to 6,000, which also proved to be insufficient to fill the trial’s arms.

  • James Doroshow: NCI-MATCH tests ability to integrate next generation sequencing

    The new iteration of the NCI-MATCH trial will test the ability on the part of cancer researchers to integrate exchanges of genomic information between academic institutions and commercial vendors, said James Doroshow, NCI deputy director for clinical and translational research and director of the Division of Cancer Treatment and Diagnosis

    “I think this is a very important test of how we can, or if we can, utilize resources across the entire country,” Doroshow said at the June 20 meeting of the NCI National Cancer advisory Board and the Board of Scientific Advisors.

  • In Brief

    • Steven Leach named director at Dartmouth Norris Cotton Cancer Center
    • Chi Van Dang appointed professor at Wistar Institute
    • Patricia Ganz named editor in chief of Journal of the National Cancer Institute
  • Drugs and Targets

    • FDA clears cooling cap treatment in solid tumor chemotherapy
    • FDA granted marketing approval to the Praxis Extended RAS Panel
    • FDA approves Endari for patients with sickle cell disease
  • Funding Opportunities

    • Call for applications – Society for Translational Oncology Fellow’s Forum
Issue 26 - Jun 30, 2017
  • Biden’s cancer nonprofit gets going

    The Bidens are now official players in the realm of oncopolitics.

    Former Vice President Joe Biden and wife Jill Biden announced the formation of the Biden Cancer Initiative, becoming the first U.S. vice president and second lady to establish and lead a cancer advocacy organization.

  • BSA, NCAB approve nine Cancer Moonshot concepts based on Blue Ribbon Panel recommendations

    The NCI Board of Scientific Advisors and the National Cancer Advisory Board unanimously approved nine Cancer Moonshot-related funding opportunity announcements.

    The approvals bring the total number of NCI Cancer Moonshot FOAs to 33, of which 11 have been closed. The FOAs are aligned with the NCI Blue Ribbon Panel scientific recommendations, which were presented to the White House less than a year ago.

  • House appropriations bill to allow NIH to move moonshot money to FDA

    Under the House version of the agriculture funding bill for fiscal 2018, NIH would be allowed to transfer Cancer Moonshot money to FDA.

    This provision of the Agriculture, Rural Development, FDA and Related Agencies bill recognizes the unintended consequences of the 21st Century Cures bill, which authorized $75 million over five years to be spent on the FDA Oncology Center of Excellence as part of the federal moonshot program. However, NIH was designated to serve as a conduit for these new funds.

  • Buchholz, Dmitrovsky and Fontaine lose authority at MD Anderson as executive vice president positions are eliminated

    MD Anderson has simplified its power structure, eliminating the three executive vice president positions and flattening out the box diagram, with six vice presidents and senior vice presidents reporting directly to the president.

    “These changes create a more diverse leadership team, built of leaders who know the institution and its needs,” the institution said in a press release. “No new hires or additional costs are needed to support the new structure.”

  • In Brief

    • Ruben Mesa new director of UT Health San Antonio
    • Claire Verschraegen to lead medical oncology division at Ohio State
    • Gideon Blumenthal named acting deputy director of FDA Office of Hematology & Oncology Products
    • Robert Haile to join Samuel Oschin Comprehensive Cancer Institute
    • Alexander Kutikov named chief of Division of Urologic Oncology at Fox Chase
    • San Diego nonprofits set to receive 2017 ASTRO Survivor Circle grants
    • ACS and Melanoma Research Alliance to fund pilot research projects
    • Michael Joiner to receive Lifetime Achievement Award from European Society of Radiotherapy and Oncology
  • Drugs and Targets

    • FDA approves Vectibix for use in wild-type ras metastatic colorectal cancer
    • FDA approves flow cytometry test for leukemias and lymphomas
    • Novartis Kisqali receives positive CHMP opinion for HR+/HER2- locally advanced or metastatic breast cancer
    • Novartis receives EU approval for Zykadia in ALK-positive advanced non-small cell lung cancer
    • FDA unveils plan to eliminate orphan designation backlog