Issue 31 - Aug 4, 2017
  • AACR’s Project GENIE about to release second dataset, creating the largest publicly available genomic database

    Project GENIE, a publicly available genomic data repository created and run by the American Association for Cancer Research, has amassed 18,804 de-identified records, and is on track to release another large dataset early this fall.

    Launched in 2015, Project GENIE, short for the AACR Project Genomics Evidence Neoplasia Information Exchange, is a multi-phase, multi-year international data-sharing initiative that seeks to catalyze precision oncology through the development of a regulatory-grade registry.

  • Conversation with The Cancer Letter

    Charles Sawyers: Project GENIE demonstrates what a coalition of willing institutions is able to do

    When former Vice President Joe Biden sought to convene and cajole cancer organizations into breaking down silos as part of the Cancer Moonshot, he frequently expressed frustration about reluctance on the part of cancer organizations to share data.

    “You’re not going to like this, but imagine if you all worked together,” Biden said at the 2016 annual meeting of the American Society of Clinical Oncology. “I’m not joking! Imagine if you all worked together.” (The Cancer Letter, June 10, 2016).

  • Ned Sharpless set to leave UNC job Aug 4; Starting date as NCI director not publicly known

    Norman “Ned” Sharpless, the scientist slated to be the next NCI director, is departing from his current job, that of director of UNC Lineberger Comprehensive Cancer Center, sources said.

    While it’s confirmed that Aug. 4 is Sharpless’s last day at Lineberger, it’s less clear what his first day at NCI would be, though insiders say he would likely report to work at the institute by the end of August.

  • Conversation with The Cancer Letter

    More than three million life-years added over 60 years as a result of SWOG clinical trials

    A SWOG study estimates that implementation of findings from that group’s clinical trials has added 3.34 million years to the lives of cancer patients in the 60 years since its founding in 1956.

    The primary question the researchers sought to answer was: “How have the NCI–sponsored network cooperative cancer research groups benefited patients with cancer in the general population?”

  • Guest Editorial

    Senate passes a “right to try” bill; Harm to patients comes next

    Patients for whom there are no existing treatments watch with desperation as a potentially helpful new drug spends years working its way from a lab bench, through clinical trials, and finally to the FDA, where reviewers consider it for approval.

    To help those who don’t qualify for clinical trials but wish to try experimental drugs as a last treatment option, the FDA allows patients’ physicians to apply for “compassionate use” of experimental medications through its expanded access program, which allows seriously ill patients without other treatment options to access investigational, unapproved drugs and devices outside of a clinical trial.

  • In Brief

    • Ramon Parsons named director of Tisch Cancer Institute at Mt. Sinai
    • ASTRO names 23 members to 2017 class of “fellows”
    • Emmanuel Quien joins the Fox Chase Cancer Center Department of Hematology/Oncology
  • Drugs and Targets

    • Enasidenib, companion diagnostic get FDA approval for relapsed or refractory AML
    • Vyxeos gets FDA approval for first treatment for types of poor-prognosis AML
    • Opdivo gets FDA accelerated approval for MSI-H/dMMR colorectal cancer
    • FDA expands ibrutinib indications to chronic GVHD
    • Amgen, Allergan submit biosimilar application for ABP 980 to FDA
    • Kite files the first CAR-T application in Europe for axicabtagene ciloleucel
    • BMS to acquire IFM Therapeutics to focus on innate immunity
    • BMS, Clovis form collaboration to evaluate Opdivo and Rubraca
    • Loxo Oncology acquires highly selective, reversible BTK inhibitor
    • MedStar Health partners with Indivumed to advance precision oncology research
  • Funding Opportunities

    • NETRF announces grants for neuroendocrine cancer research
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
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
Issue 25 - Jun 23, 2017
  • Senate appropriations subcommittee members vow to resist Trump proposal to cut NIH budget

    If the June 22 Senate appropriations hearing is an indication, President Donald Trump will encounter considerable difficulty in accomplishing his stated goal of cutting the NIH budget by 21 percent in fiscal 2018. 

    As their congressional colleagues were ramping up partisan warfare over replacement of the Affordable Care Act, members the Subcommittee on Labor, HHS, Education and Related Agencies expressed bipartisan support for providing sustained increases for biomedical research.

  • Douglas Lowy to remain deputy director of NCI as Sharpless takes over

    NCI Acting Director Douglas Lowy will continue to serve as deputy director of the institute after Norman “Ned” Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, is sworn in as the next NCI director.

    Sharpless’s appointment was announced June 9. It is not publicly known when Sharpless will be starting in his new role.

  • NCI funds research proposals based on recommendations from the Cancer Moonshot’s Blue Ribbon Panel

    Less than a year after the Cancer Moonshot’s NCI Blue Ribbon Panel identified 10 opportunities in cancer research, NCI has published 24 funding opportunity announcements to conduct research based on the panel’s scientific recommendations.

    The institute has received over 500 applications for the FOAs, said Dinah Singer, director of the NCI Division of Cancer Biology.

  • In Brief

    • CancerCare establishes Patient Values Initiative
    • National accreditation program for rectal cancer accepting applications from hospitals
  • Drugs and Targets

    • FDA approves Rituxan Hycela for DLBL and CLL
    • FDA approves Tafinlar and Mekinist for NSCLC with BRAF V600E mutation
    • FDA approves first companion diagnostic test to screen for multiple NSCLC therapies
    • FDA rejects Pfizer’s marketing application for Epogen biosimilar
    • FDA approves betrixaban for the prophylaxis of venous thromboembolism in adult patients
    • FDA accepts Amgen’s application to expand indication for Xgeva
Issue 24 - Jun 16, 2017
  • Ned Sharpless, Trump’s choice for NCI director, described as erudite scientist whose expertise spans basic, clinical research

    President Donald Trump announced his intention to name Norman “Ned” Sharpless to serve as the next NCI director. The appointment was announced late on June 9.

    Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, will replace Douglas Lowy, who has served as acting director at the institute since Harold Varmus stepped down as director in March 2015.

  • Sandoz prevails over Amgen in Supreme Court case on marketing biosimilars

    Resolving a three-year-long court fight, the U.S. Supreme Court June 12 ruled that Sandoz can commence marketing of its biosimilar white blood cell growth factor immediately after getting FDA approval.

    Amgen Inc., the sponsor of the reference agent, was seeking to make Sandoz wait for six-months after approval.

  • NIH plans to set aside up to $1.1 billion a year to fund more young investigators

    NIH is revamping its grant funding process to provide additional support to meritorious early-stage and mid-career investigators by freeing up funds from NIH’s base budget.

    The policy, called the Next Generation Researchers Initiative, would set aside about $210 million this year and ramp up that amount to $1.1 billion a year after five years—pending availability of funds.

  • In Brief

    • Immunology expert Robert Ferris named director of UPMC Hillman Cancer Center
    • Warren Kibbe to lead translational biomedical informatics at Duke
    • Tuya Pal to lead Vanderbilt’s cancer health disparities program
    • GW Cancer Center Opens Supportive Oncodermatology Clinic
    • Longnecker named Siteman Cancer Center vice president, oncology services
    • Hopkins Medicine expands collaboration with Allegheny Health Network and Highmark
    • McKesson and USON expand agreement with NCCN, adding five disease states to NCCN Value Pathways
    • ASTRO issues guideline for use of stereotactic radiation in early-stage lung cancer
  • Drugs and Targets

    • FDA approves Darzalex as combination therapy for multiple myeloma
    • FDA approves aminolevulinic acid hydrochloride as imaging agent for gliomas
    • OncoSec granted orphan drug designation for unresectable metastatic melanoma
Issue 23 - Jun 9, 2017
  • How drugs go viral: Flatiron’s real-world data show how uptake happens

    The graphs make it seem so simple:

    Doctors learn about a new therapy. They start to prescribe it. A standard of care is born. In a matter of months.

  • Conversation with The Cancer Letter

    Maria Koehler: Real-world data is “truly a revolution”

    Real-world evidence is more than just another way of tracking post-market patterns in drug utilization, said Maria Koehler, vice president of oncology strategy, innovation and collaborations at Pfizer Oncology.

    New technology for tracking real-world data may soon change the way pharmaceutical companies approach drug development. By analyzing real-time data, industry can use robust evidence from oncology practices to update drug labels, track market trends, and adjust production.

  • Francis Collins to stay on as NIH director in Trump administration

    Donald Trump has asked Francis Collins to remain in his job as NIH director.

    The move means that, as an official of the Trump administration, Collins will have to at least make an appearance of supporting its FY 2018 budget proposal, which would slash NIH by 21 percent and cut indirect costs charged by institutions that house NIH-funded researchers (The Cancer Letter, May 26).

  • Conversation with The Cancer Letter

    Michael Birrer named director of the University of Alabama at Birmingham Comprehensive Cancer Center

    Michael Birrer, an expert in early detection and treatment of gynecologic cancers, was named director of the University of Alabama at Birmingham Comprehensive Cancer Center.

    Birrer, whose job at UAB starts Aug. 1, is director of Medical Gynecologic Oncology and director of the Gynecologic Cancer Research Program at the Massachusetts General Hospital Gillette Cancer Center. Also, he serves as the leader of the Dana Farber/Harvard Cancer Center program in gynecologic cancers and is a professor of medicine at Harvard Medical School.

  • Obituary

    Angela Hartley Brodie, pioneer in the development of breast cancer treatment, dies at 82

    Angela Hartley Brodie, professor emeritus in the Department of Pharmacology at the University of Maryland School of Medicine and a scientist whose groundbreaking research is considered among the greatest advances in treating breast cancer, died of complications from Parkinson’s disease at her home in Fulton, MD. She was 82.

    Brodie pioneered the development of aromatase inhibitor. Her work developing aromatase inhibitors was a paradigm-shifting effort that began in the 1970s and was designed to reduce the level of the estrogen in the body and thereby block the growth of cancer cells.

  • Aggressive marketing transforms tobacco use into social justice issue, report states

    Tobacco use should be addressed as a social justice issue, according to a recent report by Action on Smoking and Health.

    “Aggressive industry marketing targeted at African-Americans, Native American, and the LGBTQI community and others has resulted in a disproportionate level of the overall tobacco burden being borne by those who can financially least endure it,” states a report released for World No Tobacco Day on May 31.

  • In Brief

    • Ben Melson rejoins MD Anderson as chief financial officer
    • Jeffrey Molter named director of communications at NYU Perlmutter Cancer Center
    • ACCC delivers immunotherapy education in community setting
    • Andy North & Friends raise $1.05 million for UW Carbone Cancer Center
  • Drugs and Targets

    • BMS, Novartis announce collaboration focused on metastatic colorectal cancer
    • Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients
    • FDA Approves Hologic’s Genius 3D Mammography Exam
    • Amgen and Allergan announce FDA advisory committee meeting to review ADP 215, a biosimilar candidate to Bevacizumab
    • Hitachi and MD Anderson to collaborate in research in oropharyngeal cancer
  • Funding Opportunities

    • DOD publishes research opportunities in prostate cancer
Issue 22 - Jun 2, 2017
  • Flatiron compiles rich data on the uptake of PD-1 inhibitor drugs; A case study in real-world evidence?

    Utilization data compiled by Flatiron Health and made available to The Cancer Letter make it possible to visualize the dramatic uptake of immunotherapy drugs in the academic and community settings.

    The data illustrate nothing less than the real-time anatomy of the creation of a new standard of care in oncology. Charts, bars and tables published here first show these drugs emerge in the treatment of non-small cell lung cancer in early 2015 and rapidly build momentum.

  • Conversation with The Cancer Letter

    Cary Gross: We need to learn to analyze real-world evidence rigorously

    Cary Gross, professor of medicine and of epidemiology at Yale School of Medicine, has been working with a dataset of 35,000 non-small cell lung cancer patients, looking for signs of disparities in access to PD-1 checkpoint inhibitors.

    Working with data gathered by Flatiron Health, Gross has also been pondering the role real-world evidence can legitimately play in the development and approval of cancer drugs.

  • Conversation with The Cancer Letter

    A nascent group of academics plans to conduct randomized trials to determine value of care

    group of cancer researchers is trying to conducting randomized trials aimed at maximizing the value of oncology treatment regimens. 

    The group, called the Value in Cancer Care Consortium, is headed by Allen Lichter, former CEO of the American Society of Clinical Oncology.

  • MD Anderson posts four months of positive operating margins as deficit shrinks to $43.9 million

    MD Anderson Cancer Center reported positive operating margins after posting losses over the first four months of the fiscal year.

    Between September and December, the institution’s losses totaled $169.4 million, but between January and April, operating revenues added up to $125.5 million.

  • MD Anderson settles trademark litigation with Pelotonia, Soon-Shiong

    MD Anderson Cancer Center has settled two separate trademark suits protecting the Houston-based cancer center’s Moonshot program.

    One of the actions settled was filed against Pelotonia, a non-profit that coordinates a bike ride that raises money for The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard Solove Research Institute. MD Anderson claimed in a lawsuit that Pelotonia’s taglines “One Goal” and “One Goal: End Cancer” infringe the Houston cancer center’s trademark “One goal. Stop cancer” (The Cancer Letter, April 14).

  • In Brief

    • CancerLinQ partners with FDA to study real-world use of newly approved cancer treatments
    • NCCN and CancerLinQ collaborating to provide evidence-based, decision-making resources to physicians
    • First analysis of AACR Project GENIE data is published in Cancer Discovery
    • National Breast Cancer Coalition partners with DNA.Land to crowdsource large-scale breast cancer genomics database
    • Fred & Pamela Buffett Cancer Center is dedicated in Omaha
    • University of Pittsburgh Cancer Institute becomes UPMC Hillman Cancer Center
    • Markus Müschen named to The Norman and Sadie Lee Foundation Professorship in Pediatrics at COH
  • Drugs and Targets

    • Zykadia gets first-line ALK-positive metastatic NSCLC indication
    • Advaxis and BMS announce collaboration focused on metastatic cervical cancer
    • Johns Hopkins and Eisai extend drug collaboration
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