Issue 31 - Aug 3, 2018
  • With 11 new partners, AACR’s Project GENIE to make available genomic data from 60,000 tumors by 2019

    Project GENIE, already the largest publicly available genomic data repository in the U.S., is on track to publish information on 60,000 sequenced tumors—derived from an international network largely comprised of academic cancer centers—by January 2019.

  • Conversation with The Cancer Letter

    AACR’s Sweeney: Adoption of data standards necessary for advancing real-world evidence in precision oncology

    Researchers at Project GENIE, the largest publicly available genomic database in the U.S., understand what it takes to convert sequencing data into real-world evidence: a lot of money, manpower, and data harmonization, said Shawn Sweeney, director of the American Association for Cancer Research Project GENIE Coordinating Center.

  • House committee defoliates NIH funding for WHO program that declares weedkiller Roundup a carcinogen

    The House Committee on Appropriations has withheld funding for the WHO International Agency for Research on Cancer—which receives about $2 million from the United States per year—because of controversy over the agency’s label for glyphosate, a chemical commonly used in weedkillers.

  • In Brief

    • University of Minnesota Masonic Cancer Center receives “outstanding” rating
    • Dominic Seraphin named VP of Strategic Alliances & Network at Moffitt
    • Constanza Martinez Piñanez joins Miami Cancer Institute
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  • Clinical Roundup

    • Study identifies genes associated with risk for triple negative breast cancer
    • Lung cancer mortality rates in women to increase worldwide by over 40 percent by 2030
    • Tumor Treating Fields + paclitaxel may improve survival in ovarian cancer
  • Drugs & Targets

    • FDA approves first treatment for rare adrenal tumors
    • TheraBionic P1 device receives European regulatory approval
    • Keytruda + pemetrexed and platinum gets EMA’s positive opinion for first-line NSCLC
    • Tafinlar + Mekinist gets positive CHMP opinion for adjuvant BRAF V600 mutation-positive melanoma
    • Lenvima + Keytruda get Breakthrough designation for endometrial carcinoma
    • Pfizer receives European approval for biosimilar trastuzumab
  • NCI Trials

    NCI Trials for August

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 30 - Jul 27, 2018
  • New drugs and new ideas are transforming AML

    An actuary might note that if you were in residency at the time when the 7+3 protocol of cytarabine and daunorubicin was first used to treat acute myelogenous leukemia, chances are you are considering retirement just about now.

  • Conversation with The Cancer Letter

    OSU’s Byrd: “It’s becoming necessary to consult with an expert, because it is complicated, and things are moving”

    As the landscape in acute myelogenous leukemia changes, consultations with top-tier experts have become a necessity, said John Byrd, the principal investigator of Beat AML, Distinguished University Professor, the D. Warren Brown Professor of Leukemia Research at The Ohio State University, a member of the NCI Leukemia Steering Committee, chair of the Leukemia and Correlative Science Committee within the Alliance for Clinical Trials in Oncology.

  • Conversation with The Cancer Letter

    Agios’s Schenkein: “It’s not one disease. Just like lung cancer’s not one disease”

    Agios Pharmaceuticals Inc., the sponsor of two drugs that may change the outcomes for a subset of acute myelogenous leukemia patients, is focused on more than AML.

  • FDA will organize new review divisions around disease types, Gottlieb testifies

    To modernize drug development, FDA plans to add review divisions to its Center for Drug Evaluation and Research and organize those divisions around disease types, FDA Commission Scott Gottlieb said July 25 to members of Congress in a House Energy and Commerce Committee hearing.

  • In Brief

    • DuBois, Pollak named editors of Cancer Prevention Research 
    • Walker named new COO of City of Hope
    • Manotti named senior vice president, chief development officer at MSKCC
    • Agarwal named chief medical officer at Epizyme
    • IU’s Broxmeyer receives NHLBI Outstanding Investigator Award
    • Royce, Kircher selected for ASCO’s 2018-2019 Health Policy Fellowship Program
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  • Clinical Roundup

    • UCLA’s Yang receives $1.4M to develop cellular therapy using blood stem cells
    • Takeda’s Alunbrig meets PFS primary endpoint
  • Drugs & Targets

    • FDA approves magnetic device system for sentinel biopsies in breast cancer  
    • FDA accepts Celyad IND application for CYAD-101, a non-gene edited allogeneic CAR-T candidate
    • Keytruda approved in China for advanced melanoma
    • BMS, Tsinghua University to develop therapies for autoimmune diseases, cancer
Issue 29 - Jul 20, 2018
Issue 28 - Jul 13, 2018
  • Immunologists seek ways to make TIL in solid tumors as effective as CAR T in blood cancers

    For more than four decades, Steven Rosenberg’s work on tumor infiltrating lymphocytes has met with equal measures of skepticism and cheer—but now, as more patients across multiple cancer types respond to cell transfer immunotherapy, researchers are eager to join the movement Rosenberg indisputably leads.

  • Conversation with The Cancer Letter

    NCI’s Rosenberg: Tumor infiltrating lymphocytes offer a strategy for treating recalcitrant solid cancers

    After achieving complete regression in several patients with different solid tumor types, Steven Rosenberg is eyeing the biggest prize imaginable—advancing the therapies he has championed for over four decades into the clinic as treatments for commonly occurring cancers.

  • House committee proposes $1.25 billion raise for NIH

    The fiscal year 2019 spending bill marked up by the House Committee on Appropriations gives NIH a $1.25 billion raise.

    “The National Institutes of Health, our nation’s premier biomedical agency, is funded at $1.25 billion above last year’s appropriation,” said Rep. Tom Cole (R-OK), Labor-HHS subcommittee chair.

  • In Brief

    • Gerstle named chief of Pediatric Surgery Service at MSK
    • Pestell joins CytoDyn as chief medical officer
    • Beck named COO at Leukemia & Lymphoma Society
    • UCLA’s Ribas named “Great Immigrant” by Carnegie Corp.
    • Abbott joins the Fox Chase Department of Diagnostic Imaging
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  • Clinical Roundup

    • ACA credited with earlier diagnosis of gynecologic cancers in young women
    • Phase III trial of Ninlaro meets PFS primary endpoint in multiple myeloma
    • New blood test measures four protein biomarkers, can help identify lung cancer
  • Drugs & Targets

    • FDA grants accelerated approval to Yervoy for MSI-H or dMMR metastatic colorectal cancer
    • FDA approves Xtandi sNDA for CRPC
    • FDA grants Priority Review to Merck’s sBLA for Keytruda for advanced hepatocellular carcinoma
    • Genentech submits sNDA for Venclexta for an AML indication
Issue 27 - Jul 6, 2018
Issue 26 - Jun 29, 2018
  • Senate committee proposes $2 billion raise for NIH, signaling fourth good year in a row

    When the Senate Committee on Appropriations marked up the fiscal 2019 spending bill, NIH came out ahead—$2 billion ahead.

  • NCI Director’s Report

    What NCI did with the money: Sharpless boosts funding for RPGs, centers, SPOREs, NCTN, and NCORP

    In addition to a $147 million increase to the Research Grant Project pool, NCI has added $60 million to targeted research opportunities and a $20 million increase for centers and SPOREs, and $10 million for the National Clinical Trials Network and the NCI Community Oncology Research Program.

  • Turkish oncologist Murat Tuncer jailed

    A. Murat Tuncer, a pediatric oncologist and former rector of Hacettepe University, has spent the past two months in a very uncomfortable place—the Sincan Prison in Ankara.

  • In Brief

    • Case Comprehensive Cancer Center earns “exceptional” rating, $31.9M in NCI grants
    • UPMC to advise cancer treatment center in Beijing
    • UPMC and Pitt open genome center for precision medicine, immunotherapy
    • MSKCC expands its presence in Northern New Jersey
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  • Clinical Roundup

    • Lynparza delays disease progression in phase III trial in first-line ovarian cancer
    • Tecentriq + chemo increase OS, PFS in untreated extensive stage small cell lung cancer
    • Trifluridine and tipiracil meet OS endpoint in phase III trial
    • ONS develops hazardous drugs safe handling toolkit for oncology nurses
  • Drugs & Targets

    • FDA approves Braftovi + Mektovi combination in a melanoma indication
    • Kymab, Roche agree to evaluate KY1044, anti-PD-L1 immunotherapy in solid tumors
    • FDA grants orphan drug designation for CPI-613 for Burkitt lymphoma
  • CTEP Protocol

    NCI Trials for June

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

    For further information, contact the principal investigator listed.

Issue 25 - Jun 22, 2018
  • Vinay Prasad, oncologist and Twitter star, locked in debate over precision medicine

    In recent years, Vinay Prasad, a young hematologist–oncologist at Oregon Health and Science University, has emerged as a premier critic of new directions in cancer medicine.

    In his view, cancer drugs are aimed at miniscule populations, approved way too easily, and priced too high.

  • Reviews of Prasad’s “thought experiment”

    As a reporter, I have no standing in settling scientific disputes.

    So, when Vinay Prasad and I hit the wall in our discussion of the assumptions he and a group of colleagues made in their provocative “thought experiment,” I decided to do what journals do—send the paper to peer reviewers.

  • Conversation with The Cancer Letter

    Prasad: FDA has confused merely approving drugs with making the world a better place

    have been following Vinay Prasad’s work for several years, agreeing with some of what he said, but never quite finding time to look carefully at his argumentation.

  • In Brief

    • Norman Coleman, Gay Crawford to receive NCCS Stovall Award for advancing patient-centered care
    • Marc Lippman, breast cancer expert, returns to Georgetown Lombardi
    • Laura Hutchins named interim director of UAMS Rockefeller Cancer Institute
  • Funding Opportunity

    DOD Prostate Cancer Research Program opportunities

    The FY18 Defense Appropriations Act provides $100 million to the Department of Defense Prostate Cancer Research Program to support innovative, high-impact prostate cancer research.

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  • Clinical Roundup

    • Kymriah shows more than one-year durable responses in relapsed or refractory DLBCL
    • Lonsurf improves OS in metastatic gastric cancer
    • Greater levels of vitamin D associated with decreasing risk of breast cancer
    • Diabetes diagnosis later in life may signal early pancreatic cancer in African-Americans and Latinos
    • Study finds emergency colon cancer surgery performed on weekends more likely to lead to complications
  • Drugs & Targets

    • FDA to review BRACAnalysis CDx sPMA as companion diagnostic for Talazoparib
    • China’s drug agency approves Opdivo for previously treated NSCLC
    • Natera, Institut Jules Bordet to collaborate on neoadjuvant breast cancer assay
Issue 24 - Jun 15, 2018
  • Guest Editorial

    The Trump administration “American Patients First” plan to reduce drug prices—Are American cancer patients first?

    In May 2018, President Trump announced his plan to lower drug prices. “We will have tougher negotiation, more competition, and much lower prices at the pharmacy counter. And it will start to take effect very soon,” he promised. The plan is outlined in a 40-page document by the U.S. Department of Health and Human Services titled “American Patients First—The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Cost.”

  • Change in culture needed to prevent sexual harassment at academic institutions, NASEM says

    To prevent and effectively respond to sexual harassment of women, institutions of higher education need to promote a system-wide change to the culture and climate on campus, says a new report from the National Academies of Sciences, Engineering, and Medicine.

  • In Brief

    • NCI’s Rosenberg receives Jacobson Innovation Award of the American College of Surgeons
    • Penn State Health and Highmark Health to create health care network
    • NCI renews City of Hope’s support grant with outstanding rating
    • AAP recognizes COH’s Forman for physician-led science and scientific leadership
    • COH’s Rosen inducted into the College of Fellows of the American Institute for Medical and Biological Engineering
    • Prostate cancer expert Dorff joins COH
    • COH’s Djulbegovic directs Medicine and Comparative Effectiveness Research Program
  • Funding Opportunities

    NCI Community Oncology Research Program issues three RFAs: Community Sites, Minority/Underserved Community Sites, and Research Bases

    This Funding Opportunity Announcement solicits applications from institutions/organizations to participate in the National Cancer Institute’s NCI Community Oncology Research Program (NCORP).

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  • Letter to the Editor

    MammaPrint has remained consistent and credible since introduction more than a decade ago

    To the Editor:

    One of the biggest questions that early-stage breast cancer patients face is whether they will benefit from chemotherapy treatment. Two large scale randomized clinical trials that implement genomic testing have positively addressed this question.

  • Clinical Roundup

    • Study shows low-fat diet significantly reduced risk of death after breast cancer
    • Some African-American men with advanced prostate cancer do better than whites
    • African-American men show stronger response to hormone therapy for prostate cancer
    • Loxo announces positive interim data from dose escalation trial in RET-altered cancers
    • Tecentriq, Avastin plus chemo improved OS in non-squamous NSCLC
    • Alecensa reduced risk of disease progression or death in Alk-positive metastatic NSCLC
    • Checkpoint inhibitor shrinks advanced squamous cell skin cancer
    • Kisqali combination therapy improves PFS in HR+/HER2- breast cancer
    • PARP inhibitor improves overall response rates in small cell lung cancer patients
    • Study links blood vitamin D levels to colorectal cancer risk


  • Drugs and Targets

    • FDA approves Avastin in combination with chemotherapy for ovarian cancer
    • FDA approves Keytruda for relapsed or refractory PMBCL
    • FDA approves Keytruda for previously treated patients with recurrent or metastatic cervical cancer whose tumors express PD-L1
    • TESARO, Genentech to study Zejula with anti-PD-L1 agent, MEK inhibitor in ovarian cancer
    • FDA approves Venclexta with rituximab as a fixed duration treatment for CLL or SLL after one prior therapy
    • FDA approves first Neulasta biosimilar
    • FDA, EMA accept application for talazoparib in metastatic breast cancer with inherited BRCA mutation
  • The Cancer Letter wins investigative, design awards

    The Cancer Letter won four 2018 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists.

Issue 23 - Jun 8, 2018
  • Big takeaway from ASCO: 70 percent of women with early breast cancer don’t benefit from adjuvant chemotherapy

    An NCI-sponsored trial showed that up to 70 percent of women with hormone receptor-positive, HER2-negative, axillary lymph node-negative breast cancer would not benefit from chemotherapy.

  • Conversation with The Cancer Letter

    Abrams: Only about 20-30 percent of the group might benefit from chemotherapy

    The practice-changing TAILORx trial was brought to you by publicly funded cancer clinical trials system, pointing to its continuing relevance, said Jeff Abrams, NCI acting director for clinical research and associate director of the Cancer Therapy Evaluation Program.

  • Sharpless: NCI adds $10 million for NCTN and NCORP trials

    NCI is providing an additional $10 million to support trials run with the National Clinical Trials Network and the NCI Community Oncology Research Program, Norman “Ned” Sharpless said in his first appearance as NCI director at the annual meeting of the American Society of Clinical Oncology in Chicago. “NCI’s major efforts with regards to large clinical trials are largely supported through our clinical trials networks like the National Clinical Trials Network,” Sharpless said in his June 2 talk at ASCO. “One of the major challenges for these networks over the past few years, however, has been a rapid increase in the per-patient costs for patients on trials.

  • In Brief

    • J&J Innovation and Boston University form lung cancer research alliance
    • Kochevar to retire from Colorado Cancer Center
  • Funding Opportunities

    Addario, Van Auken foundations announce 2018 Young Innovators Team Award

    The Bonnie J. Addario Lung Cancer Foundation, in collaboration with the Van Auken Private Foundation, announced the 2018 Young Innovators Team Award to fund and support teams of young investigators conducting innovative research with a potential of delivering meaningful and measurable results in the field of lung cancer.

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  • Trials and Tribulations

    Searching for Breast Cancer’s “Extreme Survivors” 

    I remember the day I met Margaret “Peg” Geisler, who has now been living with breast cancer for 40 years, and with metastatic disease for 36 of those years.

  • Clinical Roundup

    • New treatment combination improves outcomes for some patients with colorectal cancer
    • Exact Sciences, Mayo Clinic identify blood-based DNA biomarkers to diagnose hepatocellular carcinoma
    • Opdivo demonstrates superior RFS vs. Yervoy for patients with resected stage III or IV melanoma
    • Opdivo plus Yervoy provide QOL improvements in RCC
Issue 22 - Jun 1, 2018
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