Issue 25 - Jun. 23, 2017
TCL43-25 (116 downloads)

  • 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
TCL43-24 (218 downloads)

  • 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
TCL43-23 (527 downloads)

  • 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
TCL43-22 (258 downloads)

  • 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

    A 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
Issue 21 - May. 26, 2017
TCL43-21 (1490 downloads)

  • Amy Reed, physician and patient who “moved mountains” to end widespread use of power morcellation, dies at 44

    When Amy Reed enrolled at the University of Pennsylvania medical school in 2001, she could not have possibly imagined that she would save more lives as a patient than as a physician.

    The final phase of her medical education began on Oct. 17, 2013, when Reed, then 41, checked in at Brigham & Women’s Hospital—her husband’s workplace at that time—to undergo a common gynecological procedure that would fundamentally redefine her career, and, ultimately, consume her life.

  • Trump would cut over 20 percent of NIH, NCI budgets in new FY18 proposal

    The White House has proposed cutting $7.2 billion from the NIH budget, with $1.2 billion coming out of NCI—a proposal that, if supported by Congress, would eviscerate the cancer research enterprise in the United States, critics say.

    NIH stands to lose 21 percent in the Trump administration’s updated fiscal 2018 budget proposal, which would reduce the NIH budget to $26.92 billion. Also, the White House proposes to cut $1.2 billion from NCI’s budget—a 20 percent loss.

  • Obituary

    H. Jean Khoury, 50, hematologist and pioneer in leukemia research, dies

    H. Jean Khoury, an expert in hematologic malignancies at Winship Cancer Institute of Emory University, died May 22, after a year spent battling cancer. He was 50.

    Khoury, whose work focused on chronic myeloid leukemia, acute leukemia, and myelodysplasticsyndrome, joined Winship in 2004 as director of the Leukemia Program, director of the Division of Hematology, and associate professor in the Emory School of Medicine. In 2009, he was promoted to professor in the Department of Hematology and Medical Oncology, and was later named to the R. Randall Rollins Chair in Oncology.

  • ODAC votes 12-4 to recommend approval for kinase inhibitor used after completion of trastuzumab 

    The FDA Oncologic Drugs Advisory Committee May 24 voted 12-4 to recommend approval of neratinib for the extended adjuvant treatment of adult patients with early-stage ERBB2-positive breast cancer who have received prior adjuvant trastuzumab-based therapy.

    The drug, which has the trade name Nerlynx, is sponsored by Puma Biotechnology Inc.

  • In Brief

    • Carl June to receive ASCO’s Karnofsky award, Eric Winer—Bonadonna award, Brian Druker—Science of Oncology award
    • ACR Gold Medals go to Bruce Hillman, John Patti, and Jeffrey Weinreb 
    • A $100 million gift establishes a UChicago institute focused on microbiome and immunity 
    • NCI awards Fred Hutch $24 million to operate contact center for patients 
    • Karmanos wins federal grant renewal for membership in Prostate Cancer Clinical Trials Consortium 
    • NCCN funds two studies through collaboration with AstraZeneca to evaluate effectiveness of osimertinib
    • Saint Luke’s and Washington University School of Medicine announce clinical trials affiliation 

     

  • Drugs and Targets

    • Keytruda gets accelerated approval based on a genetic feature—first such action
    • Debiopharm acquires antibody-drug conjugate compound from ImmunoGen
Issue 20 - May. 19, 2017
TCL43-20 (268 downloads)

  • Conversation with The Cancer Letter

    St. Jude to boost budget by 50 percent—plans to spend $7 billion over six years on childhood cancer

    Steering clear of metaphors that stem from military campaigns and space travel, St. Jude Children’s Research Hospital is planning to spend $7 billion over six years for an expansion of clinical and research programs.

  • Conversation with The Cancer Letter

    Emory’s Winship Cancer Institute awarded Comprehensive Cancer Center designation

    Winship Cancer Institute of Emory University earned the comprehensive cancer center designation.

    Effective immediately, Winship becomes the newest NCI-designated comprehensive cancer center in the nation. The number of comprehensive cancer centers now goes up to 48. There are also 14 clinical centers and seven basic research centers.

  • In Brief

    • Peter Boyle, Tessa Holyoake receive Royal Society of Edinburgh Royal Medals
    • Richard Peto to receive William L. McGuire Memorial
    • James Downing to receive the Society of Memorial Sloan Kettering Prize
    • Stephan Grupp to lead Cellular Therapy & Transplant Section at CHOP
    • Richard Shadyac receives 2017 Ellis Island Medal of Honor
    • Roman Petrov joins the Fox Chase Cancer Center Division of Thoracic Surgery 
    • CPRIT awards $25 million in grants

  • Drugs and Targets

    • FDA’s Pazdur launches D.I.S.C.O. podcast series
    • FDA grants regular, accelerated approvals to Keytruda for urothelial carcinoma
    • CHMP recommends approval of Zykadia for ALK+ advanced NSCLC

  • Funding Opportunities

    • SU2C, Genentech announce second “catalyst” collaboration
    • DOD posts funding opportunities for Lung Cancer Research Program for Fiscal Year 2017
Issue 19 - May. 12, 2017
TCL43-19 (277 downloads)

  • How one bad sentence in the Cures Act blocked FDA’s cancer center from receiving $75 million

    The FDA Oncology Center of Excellence occupied a special place in the Obama White House moonshot program.

    Amid the moonshot’s big goals, the FDA center was concrete, manageable, and modestly priced, a reorganization that promised to revolutionize the agency’s handling of everything cancer.

  • Robert Comis, piano man, clinical trials impresario, and ECOG-ACRIN co-chair, dies unexpectedly at 71

    It’s possible that there were pianos that Bob Comis didn’t like.

    The luminary of clinical trials commandeered pianos wherever he found them—at hotel lounges and at the American Society of Clinical Oncology president’s receptions, where, year after year, he blasted his way through My Way.

  • Conversation with The Cancer Letter

    Niederhuber on Trump’s budget blueprint: “We should not panic yet”

    Former NCI director John Niederhuber is keeping relatively calm about the White House plan to slash the NIH budget.

    “I guess my reaction was that, this is the White House recommendation, the President’s recommendation,” said Niederhuber, who served as NCI director from 2006 to 2010. “When people have asked me about it, I’ve said we should not panic yet. This is a process and that’s the beginning of the process.”

  • In Brief

    • Robert Vonderheide new UPenn Abramson Cancer Center director
    • Six New York cancer researchers win Pershing Square Sohn young investigators prize
    • MD Anderson names Sabin Fellows, each to receive $100K in research funding
    • Von Hoff receives Columbia alumni award
    • Association for Cancer Immunotherapy CIMT: Cancer Immunotherapy Award to Kees Melief
    • ACCC launches financial advocacy boot camp in response to cancer costs

  • Drugs and Targets

    • Keytruda-Alimta-carboplatin combination gets FDA approval
    • FDA grants accelerated approval to avelumab for urothelial carcinoma
    • Novartis receives FDA approval for Kisqali Femara Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer
    • European Commission approves dinutuximab beta for high-risk neuroblastoma
    • Reolysin gets FDA Fast Track designation for in metastatic breast cancer 
    • PIQUR receives EMA Orphan Drug designation for PQR309 in diffuse large B-cell lymphoma
    • Addario Institute, Biocept collaborate on liquid biopsy trial in lung cancer
    • EpiThany, Merck KGaA, Pfizer to evaluate combination of avelumab and EP-101 STEMVAC in breast cancer
    • Array BioPharma, Merck collaborate to study MEK inhibitor with Keytruda
    • OncoSec, Merck to evaluate ImmunoPulse IL-12 and Keytruda in metastatic melanoma
    • Regeneron, SillaJen to test combination treatment in kidney cancer
    • Regeneron, Inovio agree to study glioblastoma combination therapy

     

  • Funding Opportunities

    • DOD Breast Cancer Research Program
    • DOD Ovarian Cancer Research Program
Issue 18 - May. 5, 2017
TCL43-18 (283 downloads)

  • Officials who fired Beckerle out at University of Utah as tables turn

    Two weeks ago, Vivian Lee and David Pershing attempted to oust Mary Beckerle from her job at Huntsman Cancer Institute.

    Now, Beckerle is back to being the CEO and director at Huntsman, while Lee is no longer the senior vice president for health sciences at the University of Utah. Lee’s boss, Pershing, too, is stepping down as soon as a new president is recruited.

  • Congress approves $2 billion increase for NIH in FY17 omnibus but FDA cancer center remains unfunded in legislative glitch

    After seven months of continuing resolutions, Congress voted to pass a $1.1 trillion spending bill covering the remainder of the fiscal year 2017—approving a $2 billion increase for NIH.

  • Impact of Proposed Cuts to NIH Budget: More Than Just About Cancer

    If enacted, the proposed budget reduction of $5.8 billion to the National Institutes of Health will slow research, deprive patients afflicted with cancer of hope, and deliver a devastating blow to our science workforce and the Commonwealth of Pennsylvania. This proposed reduction directly counters the wisdom of the U.S. Congress, who less than a year ago overwhelmingly passed the 21st Century Cures Act.

  • Faculty Senate Chair Julie Izzo: MD Anderson has evolved beyond “autocratic structure”

    MD Anderson, through its Shared Governance Committee,  is moving away from an “autocratic” structure, said Julie Izzo, chair of the Faculty Senate and an associate professor in Translational Molecular Pathology at MD Anderson Cancer Center.

  • In Brief

    • Stephen Gruber steps down as director at USC Norris
    • Bhavesh Ashar named to lead U.S. oncology business at Bayer
    • UAB expands cancer navigation program nationally with Guideway Care
    • Paul Goldberg finalist for Sami Rohr Prize

  • Drugs and Targets

    • FDA grants an accelerated approval for AstraZeneca’s Imfinzi for urothelial carcinoma
    • Draft Local Coverage Determination favorable to Oncotype DX Genomic Prostate Score
    • Opdivo gets European approval for squamous cell head and neck cancer
Issue 17 - Apr. 28, 2017
TCL43-17 (281 downloads)

  • Beckerle reinstated as director of Huntsman Cancer Institute

    A week after her abrupt firing, Mary Beckerle is back in her job as director and CEO of the Huntsman Cancer Institute.

    The remarkable turnaround comes eight days after the same leadership fired Beckerle—a highly regarded scientist who has led the cancer center since 2006—with no justification other than that she serves at the pleasure of the senior vice president for health sciences (The Cancer Letter, April 21).

  • U of Utah department chairs urge colleagues to sign petition supporting Vivian Lee

    The text of the petition follows:

    This is a critical moment. It is bigger than any one of us and it will have implications for our university and health system for years—maybe decades—to come.

    If we let the commentary and mis-characterizations of the past week go unchecked, our institution, reputation, and leadership will be damaged beyond repair.

  • Soon-Shiong and The Art of the Deal:

    Billionaire gives $12M to the U of Utah, takes $10M in orders for his company

    Under ordinary circumstances, a $12 million gift from a charitable foundation to a university is a cause for celebration.

    Indeed, in September 2014, the university put on considerable hoopla to mark a gift from three charitable entities connected to the pharmaceuticals billionaire Patrick Soon-Shiong (The Cancer Letter, April 21).

  • Tom Curran: Contract between NantHealth and U of Utah “seems a bit expensive”

    Starting in 2008, I worked closely with Peter Phillips to establish the Children’s Brain Tumor Tissue Consortium designed to generate a biorepository of rare biospecimens, with associated clinical information and genomic data, that could be shared with the research community.

  • Conversation with The Cancer Letter

    No future collaborations with NantHealth are planned, U of Utah says

    The Cancer Letter sent the following questions to the University of Utah and a nearly identical list of questions to Soon-Shiong’s spokesperson. Julie Kiefer, manager, scientific communications at the University of Utah, provided responses to these questions. No response was received from Soon-Shiong’s offices.

  • In Brief

    • SU2C awards $1 million to four research teams through Phillip A. Sharp Awards
    • Aurora Cancer Care launches precision medicine program
    • Cold Spring Harbor to collaborate with Chan Zuckerberg Initiative
    • Jason Chesney named director of University of Louisville
    • Kimberly Stegmaier wins St. Baldrick’s Foundation Arceci Innovation Award
    • Lori Brown named ONS’s first chief experience officer
    • Western IRB, Huron form alliance to serve research programs at academic centers

  • Drugs and Targets

    • FDA approves midostaurin combination for AML; Companion diagnostic also approved
    • FDA expands indications for regorafinib in hepatocellular carcinoma
    • FDA grants accelerate approval for brigatinib for ALK-positive NSCLC
    • FDA takes action against 14 companies for selling illegal cancer treatments
    • DelMar collaborates with Duke to study VAL-083 as front-line GBM treatment
Issue 16 - Apr. 21, 2017
TCL43-16 (392 downloads)