20150612 - Jun 12, 2015
ISSUE 23 – JUNE 12, 2015PDF

NCI Frederick Laboratory’s $400 Million Per Year Contract Up for Re-Competition

NCI is opening up its contract for operations and technical support at the Frederick National Laboratory for Cancer Research for re-competition—a process that officials said will take up to two years.

The institute is broadening the statement of work for the contract to maximize new opportunities in cancer research, which involves fostering interactions with academia. Bidders can include universities, consortia of universities, other nonprofit institutions and for-profit companies.

The contract, which was awarded in 2008, is scheduled to end in September 2018. Leidos Biomedical Research Inc. received $400.2 million to run the lab in fiscal 2014. It is not publicly known how much NCI is budgeting for the 2018 contract.

    21st Century Cures Heads for House Floor Vote

    The 21st Century Cures Act cleared the House Committee on Energy & Commerce and is heading for floor vote.

    The legislation, H.R. 6, is designed to expedite drug development, modernize clinical trials, and accelerate approval of drugs and medical devices. Capitol Hill insiders say the floor vote may occur within two weeks.

    Guest Commentary

    Obamacare was Undermined from the Outset

    By Leonard Zwelling

    Could the Supreme Court functionally end Obamacare before the end of June?

    It could if the court determines that subsidies paid to those individuals eligible for the payments who gained health insurance on the federal exchanges are inconsistent with the Affordable Care Act as written.

    Pediatrician Charged With Child Porn Possession Resigns From MD Anderson

    A pediatric oncologist at MD Anderson Cancer Center is facing federal charges of one count of receiving and possessing child pornography.

    Dennis Hughes, an associate professor of pediatrics, was arrested at his home June 5 after the Federal Bureau of Investigation found a thumb drive containing 8,200 downloaded files, the majority of which appeared to contain child pornography.

      In Brief

      • Karen Knudsen named director of Sidney Kimmel Cancer Center at Thomas Jefferson University

      • Roberto Pili joins IU Melvin and Bren Simon Cancer Center

      • Mary Beckerle appointed to board of Johnson & Johnson

      • Pew Charitable Trusts name 27 biomedical research scholars

      • The Cancer Genome Atlas Research Network publishes study on molecular classification of diffuse gliomas

      • AACR and Bayer partner to expand research fellowship program

      • Scripps Mercy O’Toole Breast Care Center opens in San Diego

      • ASCO Publishes Practical Tips for Oncology Practice 

      • Chris4Life Colon Cancer Foundation and Smart Patients launch DATABLUE

      • The Cancer Letter receives first place award from the Society of Professional Journalists for its coverage of power morcellation

       Drugs and Targets

      • Lenvatinib launches in U.K. for advanced thyroid cancer

      • Keytruda authorized for sale by Health Canada

      • FDA grants orphan designation to APTO-253

      • Janssen initiates rolling submission for daratumumab in multiple myeloma

      • MD Anderson and Nektar Therapeutics announce collaboration

      20150605 - Jun 5, 2015
      ISSUE 22 – JUNE 5, 2015PDF

      NCI-MATCH to Bring in Public, Private Funds, Giving NCI New Urgent Scientific Agenda

      ECOG-ACRIN Cancer Research Group is starting enrollment in NCI-MATCH, the most ambitious of NCI’s new generation of clinical trials.

      In addition to being the centerpiece of the institute’s recently formed National Clinical Trials Network, NCI-MATCH—the name is an acronym for Molecular Analysis for Therapy Choice—provides a strong case for garnering Congressional support for the White House precision medicine initiative.

      The $215 million program proposed by Obama as part of appropriations for fiscal 2016 hasn’t translated into congressional appropriations. The PMI budget request includes $70 million for NCI to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment. Similarly, the new-generation trials would boost the NCI case in pursuit of a share of another potential windfall: the 21st Century Cures.

      See also:

      Conversation with The Cancer Letter

      Doroshow: NCI-MATCH is an Example of What Smart Public-Private Partnerships Can Do

      The NCI-MATCH phase II study is intended to allow the institute and its clinical trials groups catapult to the premier role in cancer research.

      In a conversation with The Cancer Letter, James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis, said NCI-MATCH established the institute as a trusted party in a complex, multi-agent trial intended to produce leads for government-funded investigators and pharma companies would be able to follow.

      ASCO CEO Lichter to Step Down in June 2016

      Allen Lichter, CEO of the American Society of Clinical Oncology and the Conquer Cancer Foundation of ASCO, announced June 1 that he would step down June 30, 2016.

      Lichter has led ASCO since 2006.

      Melanoma Drugs Could be Used to Treat Lung, Liver, Head-Neck and Colorectal Cancers

      Three immunotherapy drugs approved for the treatment of melanoma may be used to treat advanced lung, liver, head and neck, and colorectal cancers, according to clinical trial results presented at the 2015 American Society of Clinical Oncology annual meeting in Chicago.

      These drugs—Keytruda (pembrolizumab) by Merck, and Opdivo (nivolumab) and Yervoy (ipilimumab) by Bristol-Myers Squibb—are called checkpoint inhibitors because they release the molecular checkpoints that keep the immune system from attacking tumors.

        ESMO Scale Stratifies Magnitude of Benefit of Cancer Drugs

        The European Society for Medical Oncology May 30 published the ESMO Magnitude of Clinical Benefit Scale, a tool to assist oncology clinicians in evaluating the most effective anti-cancer medicines for their patients.

        According to the society, the ESMO-MCBS offers a “rational, structured and consistent approach to stratify a drug’s clinically meaningful benefit”—a scale that can be used in public policy decision-making, to develop or improve clinical guidelines, in day-to-day clinical situations.

          Canadian Judge Orders Tobacco Companies to Pay $12 Billion to About One Million Quebec Citizens

          A Quebec court ordered three major tobacco companies to pay US$12 billion, over 15 billion Canadian dollars, in damages in a landmark class action lawsuit.

          On June 1, Quebec Superior Court Judge Brian Riordan instructed Canadian tobacco companies JTI-Macdonald, Imperial Tobacco, and Rothmans, Benson & Hedges to pay punitive and moral damages to two groups of Quebecois plaintiffs. The lawsuit was filed in fall 1998, and legal proceedings began in 2012.

            ASCO President Peter Paul Yu’s 2015 Presidential Address

            A transcript of ASCO President Peter Paul Yu’s address at the 2015 ASCO Annual Meeting.

              Amgen Seeks to Depose Reporter, TCL Invokes First Amendment Shield

              Amgen Inc. is seeking to depose The Cancer Letter editor and publisher Paul Goldberg in connection with a shareholders suit stemming from his 2007 story about the results of a Danish trial of Aranesp.

              The Cancer Letter is contesting the subpoena, asserting first amendment protection and its rights to protect confidentiality of sources.

                Obituary

                Wally Sampson, 85, Challenged Alternative Remedies

                Wallace Ira Sampson, a longtime “quackbuster,” emeritus clinical professor of medicine at Stanford University, and former director of oncology at the Santa Clara Valley Medical Center, died May 25 following a three-month hospital stay for complications following cardiac surgery. He was 85.

                Sampson was one of a group of scientists and physicians who focused on the growing influence of alternative medicine, said Stephen Barrett, a fellow quackbuster.

                  In Brief

                  • Nicole Robinson named VP of Industry Relations at Fred Hutch

                  • The Department of Defense appropriations bill includes an additional $12 million for lung cancer research

                  • The Community Oncology Alliance announces nine practices received oncology medical home designation

                  20150529 - May 29, 2015
                  ISSUE 21 – MAY 29, 2015PDF

                  Neupogen’s New Indication:

                  Nuke Mishaps and Terrorism

                  Neupogen, a drug widely used in oncology, recently received an FDA approval for boosting survival in people acutely exposed to myelosuppressive doses of radiation, also known as hematopoietic syndrome or acute radiation syndrome.

                  Neupogen (filgrastim)—a myeloid growth factor, a class of drugs that includes GM-CSF and Neulasta—as well as other similar drugs have been used to treat victims of radiation and nuclear accidents since Chernobyl.

                  “Based on my experience treating victims of many nuclear and radiation accidents worldwide, I think drugs like G- and GM-CSF may be useful in accelerating bone marrow recovery in persons exposed to moderate doses of ionizing radiations in whom sufficient numbers of undamaged bone marrow cells remain to respond and who have no irreversible damage to other tissues and organs such as the skin and lungs,” said Robert Peter Gale, an American physician who was the first physician to use these drugs in the aftermath of a nuclear accident.

                  Two Chernobyl Doctors were the First Humans to Get GM-CSF

                  By Robert Peter Gale

                  By 1986, there were substantial data in animals that molecularly-clone human haematopoietic growth factors, such as granulocyte-macrophage colony stimulating factor (GM-CSF), could accelerate bone marrow recovery and increase survival after exposure to high-dose ionizing radiations given under controlled experimental conditions.

                  On April 26, 1986, my Soviet colleagues and I were suddenly faced with treating about 200 firefighters, emergency personnel and technicians exposed to very high doses of ionizing radiations from an accident at the Chernobyl nuclear power facility in Ukraine. The most severely affected persons receiving >2 Gray (Gy; for reference the average dose of the A-bomb survivors was 10 times less and there were no survivors of doses >1 Gy) were flown to Moscow where we set up operations at Clinical Hospital 6, a high security facility attached to the Institute of Biophysics.

                  FBI Probes Who Knew What and When in Power Morcellation Imbroglio

                  The Federal Bureau of Investigation is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers.

                  According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.

                  Federal Appeals Court Instructs Tobacco Companies to Issue “Corrective Statements”

                  The U.S. Court of Appeals for the D.C. Circuit Court upheld on May 22 a lower court’s order requiring nine tobacco companies to publish “corrective statements” about the dangers of tobacco and its practices of marketing to children.

                  The ruling stems from a case the federal government brought against a group of the largest tobacco companies in 1999 under anti-racketeering law.

                    ASCO Conquer Cancer Foundation Names 2015 Winners of Young Investigator, Career Development, and Clinical Research Awards

                    The Conquer Cancer Foundation of the American Society of Clinical Oncology announced the recipients of the 2015 Young Investigator Awards, Career Development Awards, Advanced Clinical Research Award in Breast Cancer, and the Comparative Effectiveness Research Professorship in Breast Cancer.

                    The recipients will be recognized during the 2015 ASCO Annual Meeting taking place May 29 – June 2 in Chicago.

                      In Brief

                      • Shohreh Shahabi named chief of gynecologic oncology at Northwestern University

                      • Varian Medical Systems and Flatiron Health to collaborate on EMR software

                      • AbbVie completes its acquisition of Pharmacyclics Inc.

                      Drugs and Targets

                      • EU Approves Aloxi for CINV in pediatric patients

                      • CHMP issues positive opinion for change in Imbruvica label

                      • Halozyme Therapeutics and Ventana Medical Systems to collaborate on PEGPH20 assay