Issue 35 - Sep. 22, 2017
  • In a 6-6 vote, ODAC says “maybe” to Sutent for adjuvant kidney cancer—But at FDA “Maybe” has meaning

    With frustrating photo finish voting results—6-6—still on the screen, FDA’s cancer czar Richard Pazdur delivered an acerbic thank-you to members of the agency’s Oncologic Drugs Advisory Committee:

    “Well, that’s the end vote, it makes our job definitely easier,” said Pazdur, director of the FDA’s Oncology Center of Excellence, who gets sarcastic sometimes.

  • Pisters named president of MD Anderson

    Peter Pisters has been named president of MD Anderson Cancer Center and will begin in his new role later this year.

    The University of Texas System Board of Regents approved the appointment Sept. 18. Pisters, currently the president and CEO of University Health Network in Toronto, was unanimously selected as the sole finalist for the position at a board meeting Aug. 25—under state law, university government boards must name finalists for a presidency at least 21 days before making an appointment (The Cancer Letter, Sept. 1).

  • NCI outlines research priorities in annual plan and bypass budget for FY19

    NCI has released its professional judgment budget proposal for the fiscal year 2019, requesting $6.38 billion—$1 billion more than FY17—to fully fund promising areas in cancer research.

  • In Brief

    • NCI awards $12.4 million lymphoma research grant renewal to University of Iowa and Mayo Clinic
    • Roswell Park awarded contract to keep running NY Smokers’ Quitline 
    • ASTRO awards early-career research grants to physician-scientists
  • Drugs and Targets

    • Novartis’s Rydapt gets EU approval for AML and SM indications
    • FDA approves lower dose of cabazitaxel for prostate cancer
    • EMA committee issues positive opinion for Tesaro’s Zejula
    • Opdivo receives Japanese approval for advanced gastric cancer indications
Issue 34 - Sep. 15, 2017
  • Five UC Comprehensive Cancer Centers form consortium to pool patient data for translational research

    Five academic cancer centers within the University of California system are putting together a single consortium to integrate their electronic health records, forming a clinical trials monolith that could be used by pharmaceutical companies doing research in the Golden State.

    The UC Cancer Consortium, announced Sept. 11, consists of the following NCI-designated comprehensive cancer centers:

    • University of California, Davis Comprehensive Cancer Center,
    • The Chao Family Comprehensive Cancer Center at University of California, Irvine,
    • The Jonsson Comprehensive Cancer Center at University of California, Los Angeles,
    • University of California, San Diego Moores Cancer Center, and
    • University of California, San Francisco Helen Diller Family Comprehensive Cancer Center.
  • Conversation with The Cancer Letter

    Ashworth’s challenge: Build one very big data sharing system across the University of California cancer centers

    As the inaugural chair of the University of California Cancer Consortium, Alan Ashworth has to do a little cheerleading and a lot of pushing for integration of the electronic health records across the UC cancer centers.

    All five cancer centers use Epic, but that doesn’t mean much. “We’re all on Epic—but they’re all different instances,” Ashworth said to The Cancer Letter. “So, we need another solution to put all these things together.

  • Gottlieb: Oncology center shows how FDA can improve regulation, lower development costs

    FDA has a legitimate role to play in slowing down the cost of developing drugs, and it can do so by relying on good regulatory science, the agency’s commissioner Scott Gottlieb said.

    Speaking at a Washington event sponsored by Friends of Cancer Research and focused on precision medicine, Gottlieb said the agency’s Oncology Center of Excellence demonstrates what the agency can do to streamline the drug development process.

  • Conversation with The Cancer Letter

    The Next Step: Neil Hayes picks up stakes at UNC to build an NCI-designated cancer program in Memphis

    The Next Step is an occasional series of conversations in which The Cancer Letter will focus on cancer researchers in the midst of transition from one position to another.

    Here we sit down with Neil Hayes, who after 15 years at the UNC Lineberger Comprehensive Cancer Center, where he was most recently a co leader of the Clinical Research Program, is leaving for Memphis to become the scientific director of the University of Tennessee West Institute for Cancer Research.

  • In Brief

    • Teitell named director of the UCLA Jonsson Comprehensive Cancer Center
    • AACR calls for sound policy, sustained funding increases
    • Allison, Schreiber win 2017 Balzan Prize 
    • Mannel Appointed as an NRG Oncology Group Chairman
    • Marcus named associate director for basic research, shared resources at Winship
    • Nominations open for AACR-Waun Ki Hong Award for translational and clinical cancer research
    • Vanderbilt’s Penson named to JNCI editorial post
    • Roswell Park joins the Oncology Information Exchange Network
    • Kimmel Cancer Center to open welcome center
  • Drugs and Targets

    • Bayer’s Aliqopa gets FDA accelerated approval for relapsed follicular lymphoma
    • FDA approves Amgen’s Mvasi, a bevacizumab biosimilar
    • Cemiplimab receives FDA breakthrough designation for advanced cutaneous squamous cell carcinoma
Issue 33 - Sep. 8, 2017
  • NCI’s Lowy and Schiller win Lasker prize for developing HPV vaccine

    Douglas Lowy and John Schiller have won the 2017 Lasker-DeBakey Clinical Medical Research Award for research that led to development of the human papillomavirus vaccine.
    Lowy, who is completing his stint as the NCI acting director, becomes the first head of the institute—permanent or acting—to win the award, which is described as America’s Nobel Prize.

    The Lasker awards were announced Sept. 6.

  • Conversation with The Cancer Letter

    Lowy: NCI’s intramural program made development of the HPV vaccine possible

    After getting the news that he and collaborator John Schiller have won the 2017 Lasker-DeBakey Clinical Medical Research Award, Douglas Lowy said that part of the credit belongs to the NCI intramural research program.

    Lowy and Schiller got the award for their role in developing the human papillomavirus vaccine, likely preventing millions of deaths worldwide from cervical cancer and HPV-induced malignancies.

  • Another doubling in progress for NIH? Senate appropriators slate $2 billion for NIH in FY18

    The Senate Appropriations Committee Sept. 7 marked up its version of the fiscal 2018 Labor-HHS spending bill, giving NIH an increase of $2 billion over the current year.

    The bill was approved with overwhelming bipartisan support, with a 29-2 vote, and will advance to the White House as soon as the House passes similar legislation. If signed into law, the measure would bring NIH’s budget to $36.1 billion, marking the third year in a row that NIH has received a $2 billion increase.

  • Guest Editorial

    How the RACE for Children Act will get drugs to kids with cancer

    This month, I should be taking my son, Jacob, to college. Instead, I’m participating in Curefest for Childhood Cancer on the Mall here in D.C.

    When Jacob was eight, he was diagnosed with medulloblastoma. The drugs used to treat Jacob were almost 40 years old. They did not work.

  • In Brief

    • H. Richard Alexander named chief surgical officer at Rutgers
    • Weill Cornell awarded $11.3 million SPORE grant for prostate cancer 
    • Fox Chase receives NIH grant to establish a research center in Jamaica
    • NCCN Chemotherapy order templates to be integrated into MEDITECH’s Web EHR
    • ASTRO honors 43 researchers with Abstract Awards at 2017 Annual Meeting
  • Drugs and Targets

    • EC approves Merck’s Keytruda for locally advanced, metastatic urothelial carcinoma
    • FDA grants orphan drug status to Cellect’s ApoGraft for acute and chronic GvHD
  • Funding Opportunities

    • DOD Kidney Cancer Research Program publishes funding opportunities for FY17
Issue 32 - Sep. 1, 2017
  • Peter Pisters tapped to lead MD Anderson

    Peter Pisters, a sarcoma and pancreatic cancer surgeon and an MD Anderson expat who serves as president and CEO of University Health Network of Toronto, is set to become the fifth president of the Houston-based cancer center.

    Pisters was chosen by the UT System Board of Regents at a special meeting Aug. 25.

  • NCI requests $591 million in additional funding for FY19

    NCI is asking for $6.38 billion for fiscal year 2019­—nearly $1 billion, or 12 percent, above FY17 appropriation levels—to fully fund promising research areas.

    The institute’s FY19 professional judgment budget proposal, also known as the Bypass Budget, is a unique authority established by the National Cancer Act of 1971.

  • In Brief

    • Guenther Koehne named chief of bone marrow transplantation and hematologic oncology at Miami Cancer Institute
    • Prostate Cancer Foundation awards $6 Million in 2017 Challenge Awards
    • Rick Kittles joins City of Hope as director of the Division of Health Equities
    • William Dale joins City of Hope as professor of supportive care
    • Deric Savior promoted to head of medical oncology at Temple University Hospital
    • Carlyn Tan joins department of hematology/oncology at Fox Chase 
    • Reza Nejati joins pathology department at Fox Chase
    • CPRIT awards $102 million in 60 new grants 
  • Drugs and Targets

    • Novartis’s Kymriah becomes first gene therapy to get FDA approval
    • FDA approves Mylotarg for treatment of acute myeloid leukemia
    • FDA approves Lynparza (olaparib) tablets for maintenance treatment in ovarian cancer
    • FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL
    • Ocugen gets Orphan Drug designation for ocular graft vs. host disease
    • Gazyva in previously untreated follicular lymphoma gets FDA priority review 
    • EU approves AVEO’s Fotivda (tivozanib) for advanced renal cell carcinoma
    • FDA acts to remove unproven treatment used in ‘stem cell’ centers
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
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