Issue 34 - Sep 16, 2016
  • ODAC Slams Spectrum for Massaging Data From Two Bladder Cancer Trials

    A brief consult with an undergraduate earning a B or above in Statistics 101 might have acquainted Spectrum Pharmaceuticals executives with all the science that would have saved them from a devastating encounter with an FDA advisory committee.

    Yet, there they were, black suits and all, at a suburban Maryland conference center, watching the Oncologic Drugs Advisory Committee vote unanimously against approval of Spectrum’s bladder cancer therapy Qapzola (apaziquone). 

    During the Sept. 14 meeting, FDA officials said repeatedly that taking apaziquone, a drug chemically related to mitomycin, to ODAC wasn’t their idea.

  • White House: New Moonshot Initiatives On Clinical Trials Will Improve Speed, Access

    Vice President Joe Biden Sept. 16 announced a series of initiatives to improve the safety, accessibility, and impact of clinical research—one of the central goals of the National Cancer Moonshot Initiative.

    The programs, which span four federal entities—NCI, FDA, the Department of Health and Human Services, and NIH—would make existing clinical trial search sites more user-friendly, and ensure that results of clinical trials are shared in a timely fashion.

  • NCI Director’s Report

    Lowy: RPG Funding Increased by $100M From 2013 to 2015—150 More Grants Funded

    Research Project Grant funding at NCI has increased 25 percent, from $400 million in 2013 to $500 million in 2015, NCI Acting Director Douglas Lowy said to the National Cancer Advisory Board Sept. 7.

    NCI’s fiscal 2016 budget is $5.21 billion, an increase of $260.5 million over fiscal 2015. This represents the  first time in about three years that funding for the institute has recovered to above pre-sequestration levels.

  • Abcodia Suspends Sale of Ovarian Cancer Screening Test After FDA Communication

    Abcodia Inc., a British company that manufactures a controversial ovarian cancer screening test, said it will temporarily suspend the availability of the product in the United States.

    ROCA, also known as the Risk of Ovarian Cancer Algorithm, uses a blood test called CA-125 and patients’ history to determine their risk for developing ovarian cancer.

  • Obituary

    John Bailar, Epidemiologist and Critic of War on Cancer, Dies at 83

    John Christian Bailar III, an epidemiologist and biostatistician known for his criticism of NCI’s emphasis on treatment, died Sept. 6. He was 83.

    Bailar riffed on the bellicose language of President Richard Nixon’s “War on Cancer” to suggest that the war in question was being lost. Researchers have focused too much on treatment and not enough on prevention, he argued.

  • Obituary

    Hopkins Biologist Saul Sharkis Dies at 72; Studied Blood Stem Cells’ Role in BMT

    Saul Sharkis, a scientist who studied the biology of blood stem cells and how they could be used to treat cancer through bone marrow transplantation, died Sept. 4. He was 72.

    Sharkis was a professor of oncology at the Johns Hopkins University School of Medicine and a faculty member in the Johns Hopkins Kimmel Cancer Center for more than 40 years.

  • In Brief

    • Eric Fearon named director of the University of Michigan Comprehensive Cancer Center
    • William Kaelin, Peter Ratcliffe, and Gregg Semenza receive 2016 Lasker Award for basic medical research
    • NCI publishes full list of FY2016 SPORE grantees
    • NCCN collaborates with New Century Health to integrate Imaging Appropriate Use Criteria
    • Levi Garraway succeeds Richard Gaynor as Lilly Oncology senior vice president, Global Development & Medical Affairs
    • Brian Goldstein named chief health system officer of UW Medicine and vice president for medical affairs at the University of Washington
    • Ashani Weeratna named Ira Brind Associate Professor at the Wistar Institute
    • Thomas Imperiale named inaugural Lawrence Lumeng Professor in Gastroenterology and Hepatology at Indiana University School of Medicine
    • The Terry Fox Foundation awards $27.3 million to six Canadian research teams
    • FDA issues first warning letters for selling e-cigarettes, e-liquids and cigars to minors
    • FDA modifies dosage regimen for nivolumab (Opdivo) for the currently approved indications
    • The European Commission issues marketing authorization for lenvatinib (Kisplyx) in combination with everolimus
Issue 33 - Sep 9, 2016
  • NCI’s Moonshot Advisory Panel Identifies Ten Opportunities in Cancer Research

    The Blue Ribbon Panel—a group of experts selected to identify scientific opportunities for the National Cancer Moonshot Initiative—has submitted 10 recommendations to the National Cancer Advisory Board.

    The panel proposes creating tumor atlases and national networks for patient engagement, immunotherapy clinical trials, and data sharing. Recommendations also include supporting research on drug resistance, fusion oncoproteins, symptom management, and development of cancer technologies.

    “The Blue Ribbon Panel recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease,” the authors write.

  • Conversation with The Cancer Letter

    Lowy: Implementation Will Depend on NCI Funding in Fiscal Year 2017 and 2018

    NCI will urge increased and sustained appropriations for carrying out ten recommendations put forward by the Blue Ribbon Panel, the institute’s scientific advisory panel to the National Cancer Moonshot Initiative.

    On Sept. 7, NCI Acting Director Douglas Lowy accepted the recommendations of the Blue Ribbon Panel, which presented its report to the National Cancer Advisory Board.

    “To the extent that NCI would be involved in making a case to Congress, we would be talking about the scientific validity of what is being recommended as a really important way of augmenting what NCI is already doing,” Lowy said.

  • FDA Warns Against Ovarian Cancer Screening

    FDA has recommended against the use of ovarian cancer screening tests, regardless of risk level.

    In a safety communication published Sept. 7, the agency warned women and their physicians against relying on “unproven” technology. No study published to date has provided reliable evidence that ovarian cancer screening saves lives, the agency said.

    “FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions,” FDA said in a statement. “Available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”

  • Obituary

    Robert Frelick, Former CCOP Program Director, Dies at 96

    Robert Westscott “Dr. Bob” Frelick died Sept. 1, 2016. He passed away in his sleep after an accident and short illness. He was 96.

    Born in 1920, in Potsdam NY, Frelick graduated from Union College, Schenectady NY and received his medical degree from Yale University School of Medicine.

    He joined the U.S. Army Reserve in 1942, rising to the rank of captain. After marrying Jane Owen Hayden in 1944 and serving a medical internship at New Haven Hospital in Connecticut, he went on active duty with the U.S. Army in 1945, first assigned to Madigan General Hospital in Fort Lewis WA, and then to the Army of Occupation in Munich, Germany.

  • In Brief

    • Washington University receives $10.4 million NCI SPORE grant
    • Hollings Cancer Center receives $8 million grant from the National Institute of Minority Health and Health Disparities
    • Jacques Galipeau joins the faculty of the University of Wisconsin Carbone Cancer Center
    • Frank Vrionis to become director of Boca Raton Regional Hospital’s Marcus Neuroscience Institute
    • The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) awarded three grants to investigators
    • Bassel El-Rayes to hold the John Kauffman Family Professorship for Pancreatic Cancer Research
    • Michael Jan Bartel joins the Department of Medicine as a gastroenterologist at Fox Chase Cancer Center
    • Allison Aggon joins the Department of Surgical Oncology at Fox Chase Cancer Center
    • The Cincinnati Children’s/UC Health Proton Therapy Center opened with the ProBeam System from Varian Medical Systems
    • Ruth Browne to become new president and chief executive officer of the Ronald McDonald House
    • The Prostate Cancer Foundation announces five new Movember Foundation-PCF Challenge Awards
    • The American Society for Radiation Oncology selects 44 cancer researchers and clinicians to receive a total of $36,500 in individual awards 

     

  • Drugs and Targets

    • 21 hospitals across China will adopt Watson for oncology
    • Amgen acquires rights from Boehringer Ingelheim for BI 836908 (AMG 420)
    • FDA accepts Array Biopharma’s NDA for binimetinib
    • Cumberland Pharmaceuticals begins distributing Ethyol (amifostine) for injection
    • EMA accepts for review Mylan’s MAA for a proposed biosimilar trastuzumab
    • BTG International Canada receives approval from Health Canada for DC Bead LUMI
    • Palmetto GBA issues final local coverage determination for ProMark
    • Regeneron Pharmaceuticals and Adicet Bio to develop next-gen engineered immune cell therapeutics

     

Special Report - Sep 7, 2016
  • NCI’s Moonshot Advisory Panel Identifies Ten Opportunities in Cancer Research

    The Blue Ribbon Panel—a group of experts selected to identify scientific opportunities for the National Cancer Moonshot Initiative—has submitted 10 recommendations to the National Cancer Advisory Board.

    The recommendations include creating tumor atlases and national networks for patient engagement, immunotherapy clinical trials, and data sharing, and supporting research on drug resistance, fusion oncoproteins, symptom management, and development of cancer technologies.

    “The Blue Ribbon Panel recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease,” the authors wrote.