Issue 7 - Feb 16, 2018
  • A confusing Valentine: White House proposes cutting NIH by 27 percent, and—at the same time—reverses the cut

    What a difference a week makes.

    Last week, advocates for biomedical research were bracing for another shutdown of the federal government and fearing that the president’s budget proposal for fiscal year 2019 would drastically slash NIH.

  • NCI Director’s Report

    Sharpless: NCI should increase funding for RPG pool to maintain success rates for R01s

    NCI may need to invest at least $125 million in new money in the Research Project Grant pool in 2018 if the institute plans on keeping the success rates for R01s comparable to 2017, said NCI Director Ned Sharpless.

  • In Brief

    • NCI’s Lowy and Schiller win Szent-Györgyi Prize
    • Aldape starts as chief of laboratory of pathology at the NCI
    • Aghajanian appointed as NRG Oncology Gynecologic Cancer Committee Chair
    • Hudson named co-chair of NRG Oncology Delivery Research Committee
    • AACR’s Cancer Today magazine launches new website

     

  • Funding Opportunities

    American Cancer Society Supports Early Career Clinicians’ Move into Clinical Science

    The American Cancer Society started a grant program to support early career clinicians aiming to become clinician scientists.

  • Trials and Tribulations

    A Cancer Patient’s War on Cancer

    Imagine a hospital ward 100 years from now. Will multi-drug resistant infections be as prominent as they are today? I suspect so, because as antibiotics evolve, so will the infectious diseases they target. It’s an arms race in which both sides have a capacity to learn and adapt. Not so cancer. Cancers can’t learn from each other. But cancer patients can. This profound imbalance in the capacity for learning is an advantage that all cancer patients share. It is our super power. And we barely use it.

  • Clinical Roundup

    • NCCN & ASCO provide joint guidance on side effects from checkpoint inhibitors
    • Phase II trial shows durvalumab active in recurrent or metastatic head and neck cancer
    • UW Carbone study finds caregiver spouses of cancer patients suffer untreated depression
  • Drugs and Targets

    • FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
    • Roche to acquire Flatiron Health for $1.9 billion
    • BMS, Nektar form collaboration for CD122-biased agonist
    • Tivozanib gets NICE nod for first-line treatment of advanced RCC
Issue 6 - Feb 9, 2018
  • Dissenters in anti-tobacco movement cite National Academy report in claim that “e-cigarettes are saving lives.” Nope, the NAS report’s authors say

    A group of tobacco control advocates, one of whom receives money from Philip Morris International, issued a press release trumpeting that “E-Cigarettes are Saving Lives,” and attributed this conclusion to a recent report by the National Academy of Sciences, Engineering, and Medicine.

  • Conversation with the Cancer Letter

    NTRI’s Abrams: Smokers should use e-cigarettes if they can’t quit completely

    Withholding e-cigarettes as an alternative from smokers who are unable to quit equals supporting the continued use of conventional cigarettes, said David Abrams, a member of the National Tobacco Reform Initiative.

    “The main thing you want to get across with the NASEM report and others is that smokers should absolutely try to find an e-cigarette that works for them if they can’t quit completely,” said Abrams, professor, Department of Social and Behavioral Sciences at the New York University College of Global Public Health. “The public have been very much misled and wrongly believe that e-cigarettes would not help you quit.”

  • An Appreciation

    Cancer moves fast…and we have to move faster

    Jon M. Huntsman Sr. dared to eradicate cancer from the face of the earth. People thought he was crazy, but for someone who started out delivering fresh eggs as a boy to support his family, went on to invent and then manufacture the polystyrene egg carton, and built from scratch a $12 billion global chemical company with more than 12,000 employees, there was no holding him back. Jon was a dreamer, a risk-taker, a true visionary, and a man whose compassion for others knew no limits. He didn’t sleep. His life was dedicated to making the world a better place: a world without homelessness, a world without hunger, a world without cancer.

  • Congress passes two-year budget deal, paving the way toward giving NIH a $2 billion raise

    So, the federal government shut down while America slept, but it reopened after a five-and-a-half hour pause, by early morning Feb. 9. We’ve seen this dance before.

    However, in a move that is anything but yawn-inducing, Congress passed a budget deal that paves the way toward giving NIH a $2 billion raise and lifts the spending caps on defense and non-defense spending through March 2019.

  • CRUK names ten finalists for £20m Grand Challenge

    Cancer Research UK has shortlisted ten multidisciplinary, international teams for what amounts to the second leg of competition for Grand Challenge awards.

    Each of the teams will now receive £30,000 in seed funding to prepare up their applications for interviews later this year.

  • In Brief

    • Arap, Pasqualini named to leadership posts at Rutgers Cancer Institute of New Jersey at University Hospital in Newark
    • Dhodapkar named director of new Center for Cancer Immunology at Emory Winship
    • Oberstein named director of GI medical oncology at NYU Perlmutter Cancer Center  
    • Campbell joins Fox Chase Cancer Center Cancer Biology Program
    • IU gets $14 million gift to create program focused on symptom management
  • Clinical Roundup

    • In phase III study Tecentriq and Avastin reduced risk of disease worsening/death by 26 percent in advanced kidney cancer
    • Opdivo plus Yervoy meet PFS endpoint in phase III trial in frontline NSCLC
    • Tyme announces interim phase II data for SM-88 in prostate cancer at ASCO GU Symposium  
  • Drugs and Targets

    • FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer
    • Foundation Medicine and EORTC collaborate comprehensive genomic profiling
    • Abbott PathVysion HER-2 DNA Probe assay to be used in ANGLE study
Issue 5 - Feb 2, 2018
  • Like it or not, CMS policy aims to change everything in Next generation sequencing

    A policy now in the works at the Centers for Medicare and Medicaid Services will define settings where Medicare will pay for next generation sequencing.

    The health care funding agency will use FDA approval of NGS tests to determine whether these tests are covered outright, receive “coverage with evidence development,” or are denied coverage altogether.

  • Dear CMS, Here’s what I think about your NGS policy… Agency draft memo garners 315 comments

    The range of opinions reflected in the 315 comments CMS received on its proposal for Medicare payment for Next Generation Sequencing reflects the extent of controversy over the test.

  • Conversation with the Cancer Letter

    Miller: “Doctors and patients have confidence in knowing that a test has gone through FDA”

    Concurrent FDA approval and the establishment of Medicare coverage will propel Next generation sequencing squarely into the mainstream of oncology practice, said Vincent Miller, chief medical officer of Foundation Medicine Inc.

  • In Brief

    • Mays Family Foundation makes legacy gift of $30 million to UT Health San Antonio Cancer Center
    • Sylvester Comprehensive Cancer Center to build proton therapy program
    • Syapse partners with Seoul National University Hospital and Megazone
    • Buchholz named medical director at Scripps MD Anderson Cancer Center
    • Kati Stoermer named executive director NRG Oncology
    • James Wade joins Vibrent Health as chief medical informatics officer
    • SU2C announces $11 million multi-disciplinary research program
    • Chen, Bild, Kahn, Heisterkamp join City of Hope
    • New building expands inpatient care at Siteman Cancer Center
    • CancerCare raises nearly $665,000 to support patients affected by hurricanes
    • Cancer Support Community adds Digital Nonprofit MyLifeLine to its network
  • Funding Opportunities

    AACR announces AACR-J&J lung cancer innovation science grants

    The American Association for Cancer Research has launched the AACR-Johnson & Johnson Lung Cancer Innovation Science Grants.

    A total of $4.5 million will be made available in research funding. Three multi-institutional research teams that seek novel approaches to the prevention, interception, and cure of lung cancer will each be awarded up to $1.5 million over three years.

  • Trials and Tribulations

    Re: Drug Pricing My unsolicited advice to HHS Secretary Alex Azar

    Dear Mr. Azar:

    I am the leader of CancerCare, a national organization that provides free, professional support services to anyone affected by cancer. I’m writing this letter to offer some perspective regarding the plight of nearly 16 million U.S. cancer survivors, the many more who are family and care providers, and all of those who will be diagnosed in the coming years.

  • Clinical Roundup

    Trial shows durable remissions with Kymriah in children, young adults with r/r ALL

    Novartis has announced updated results from the pivotal ELIANA clinical trial of Kymriah (tisagenlecleucel), formerly CTL019, in relapsed or refractory (pediatric and young adult patients with B-cell acute lymphoblastic leukemia have been published in The New England Journal of Medicine. New data include longer-term follow-up and efficacy in 75 infused patients, analysis of expansion and persistence of Kymriah, and longer-term safety.

  • Drugs and Targets

    • FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS
    • Amgen receives CHMP positive opinion to add updated survival data to Kyprolis label
    • Syndax announces immuno-oncology collaboration with AstraZeneca
Issue 4 - Jan 26, 2018
Issue 3 - Jan 19, 2018
  • Guest Editorial

    A unique drug for each patient: a paradigm shift in cancer therapy

    The recent FDA approvals of a cell/gene therapy for patients with advanced B cell malignancies provide a glimpse into a paradigm shift in the treatment of hematologic and solid cancers, the creation of a new drug unique to each cancer patient.

  • News Analysis

    As government shutdown looms, don’t lose sight of bigger battle over appropriations, sequestration

    As the rancor in Washington continues to escalate from bickering to a war on many fronts, the deadline approaches for the end of a continuing resolution that keeps the federal government open until Jan. 19.

  • In Brief

    • Allison, Bax, Doudna and Chang receive NAS prizes
    • Kathy Albain receives first Huizenga Family Endowed Chair at Loyola University Chicago
    • ACS CAN: Cancer patients should be exempt from possible Medicaid work requirements
    • ACCC’s 2017 survey: cost of treatment is top threat to cancer program growth
  • Clinical Roundup

    • Blood test for eight cancer types provides framework for early detection
    • Study shows screening population for select genes is a cost-effective solution
    • Polygenic hazard score predicts when men develop prostate cancer
    • Exelixis and Ipsen announce phase III trial results of Cabozantinib in advanced hepatocellular carcinoma
  • Drugs and Targets

    • Foundation Medicine and Pfizer form partnership to develop companion diagnostics
    • FDA approves addition of overall survival data to Kyprolis
    • Novartis granted FDA Priority Review for Kymriah for adults with r/r DLBCL
  • CTEP Protocols

    NCI CTEP-Approved Trials for January

    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 2 - Jan 12, 2018
Issue 1 - Jan 5, 2018
  • ASCO forms collaboration with two Big Data firms to grow CancerLinQ

    The ten-year collaboration, announced Dec. 21, gives Tempus and PH.AI access to de-identified data from over a growing database of more than a million records contained in CancerLinQ.

    ASCO and its new commercial partners will continue to expand CancerLinQ and, at the same time, look for better ways to aggregate and mine the data. The data could be used in drug development as well as scientific projects and quality initiatives.

  • Conversation with the Cancer Letter

    Hudis: ASCO needed collaborators to help CancerLinQ deliver faster on its mission

    “This is a licensure and a strategic collaboration. This leverages the expertise of several organizations to allow us to deliver real value to our members and subscribers faster than we would have been able to otherwise.”

  • Conversation with the Cancer Letter

    Lefkofsky: CancerLinQ has value in ushering in an era of precision medicine

    “This gets a bit into Tempus’s business model and at least how we view the world. This data has some commercial applicability today. But the real value in this data is in how do you build much larger, much more comprehensive datasets that actually can be used to usher in an era of precision medicine.”

  • Introducing the clinical section of The Cancer Letter

    Today’s issue of The Cancer Letter contains a new section devoted to clinical news.

    As part of our new format, stories that have immediate clinical significance will appear in every issue, much like a sports or business section in a newspaper.

  • An Appreciation

    Jimmie Holland, founder of psycho-oncology, dies at 89

    Jimmie C. Holland, internationally recognized as the founder of the field of psycho-oncology, died suddenly on Dec. 24, 2017, at the age of 89.

  • An Appreciation

    Gerald Hanks, pioneering radiation oncologist, dies at 83

    Gerald E. Hanks was a giant in the world of radiation oncology and oncology in general. It isn’t often that we can say this and probably understate a person’s significance and influence, but Jerry was one of those people.  He died on Dec. 20, 2017, at the age of 83.

  • In Brief

    • Howard “Skip” Burris elected ASCO president for 2019-2020
    • Hochster named associate director, clinical research, and chief of GI med/onc at Rutgers
    • Whitten named president of Taiho Oncology
    • Purdue Center for Cancer Research receives $10 million from Walther Cancer Foundation
    • METAvivor announces 2017 grant awards for metastatic cancer research
    • JAX starts canine cancer initiative to find predictors, treatments for humans, dog
  • Trials and Tribulations

    Cabozantinib in first-line treatment of metastatic renal cell carcinoma

    Systemic therapies for metastatic renal cell carcinoma (mRCC) have expanded dramatically over the past 3 years.

  • Clinical Roundup

    • CAP publishes guideline to ensure accurate HPV testing in head and neck cancers
    • CAR-T therapy cancer study published in the New England Journal of Medicine
    • Cancer mortality in the U.S. continues decades-long drop
  • Drugs and Targets

    • FDA approves Perjeta in adjuvant breast cancer
    • FDA approves Cabometyx for previously untreated advanced renal cell carcinoma
    • FDA approves Pfizer’s Bosulif (bosutinib) for newly-diagnosed Ph+ CML
    • FDA approves Xgeva for prevention of skeletal-related events in multiple myeloma
    • Kisqali receives breakthrough designation for HR+/HER2- breast cancer
    • FDA accepts sBLA, grants priority review for Adcetris
    • FDA grants breakthrough designation for Avelumab in combination with Inlyta in RCC
    • FDA grants orphan drug designation to Aptose Biosciences for CG’806 in AML
    • FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated NSCLC
    • FDA grants priority review for Apalutamide in non-metastatic castration-resistant prostate cancer
    • Janssen and Legend Biotech enter deal to develop CAR-T therapy
Issue 46 - Dec 15, 2017
  • “We’re gonna free the data,” Sharpless pledges at NCI Town Hall

    In his first talk to  NCI staff, director Norman “Ned” Sharpless presented himself as an institute insider—highlighting his career-long relationships with NCI and its “legends,” demonstrating his grasp of the institute’s agenda and research portfolio.

  • Five health systems join Strata Oncology network to sequence and match patients to targeted therapy trials

    Five health care systems have joined a precision oncology network that sequences patients’ tumors at no cost and matches patients to clinical trials.

  • As FDA, AHRQ spar over incidence estimates for uterine sarcomas, FDA reiterates recommendation to restrict power morcellation

    About one in 225 to one in 580 women who undergo surgery for fibroids may have hidden uterine cancers, FDA concluded in a recent review of medical studies published over the past four years.

    The updated estimate is generally consistent with one contained in the agency’s 2014 review, FDA officials said in a statement Dec. 14. Three years ago,  the agency estimated that  one in 350 women undergoing such surgery may have a previously undiagnosed sarcoma.

  • Anticipating fundamental change in oncology

    In 2017, The Cancer Letter’s readership grew by over 40 percent and the number of page views has nearly doubled from the 2016 level.

    On an average day in 2017, our website got over 1,700 visits and over 12,500 page views. By way of comparison, in 2016, we gauged 1,200 visits and 6,800 page views. We are losing the right to call ourselves a small publication.

  • In Brief

    • AACR urges House-Senate conference to remove tax bill provisions penalizing future scientists, patients, survivors
    • 2017 AACR-Bayer Innovation and Discovery Grants recipients announced
    • USPSTF recommends against hormone therapy for preventing chronic conditions 
    • Jason Incorvati joins hem/onc department at New Fox Chase East Norriton Campus
  • Drugs and Targets

    • Fate Therapeutics completes technology transfer and starts IND-enabling manufacture of FT500
Issue 45 - Dec 8, 2017
  • Building a “hybrid” center by the Beltway, Trump pursues vision of a new national research network

    As he goes about the task of building a cancer center, Donald “Skip” Trump has to align the money, the real estate, the recruitment—all the customary components of an institution.

    Sure, all of this is more complex because Trump is building the Inova Schar Cancer Institute in hyper-competitive and wealthy Northern Virginia, literally by the outer loop of the Beltway.

  • FDA considers using data from approved indications to support regular approvals of sNDAs based on intermediate endpoints

    FDA officials are floating a proposal for a review process informally dubbed “reverse accelerated approval.”

    This mechanism would come into play in situations where the data that have already been provided to the agency may justify approval of supplemental indications.

  • Guest Editorial

    Tobacco companies finally have to say smoking causes cancer

    These statements may not be breaking news for oncologists and other physicians, who should have been aware of the lethal nature of cigarette smoking at least since the publication of the first Surgeon General’s report on Smoking and Health more than half a century ago.

  • In Brief

    • William Oh named deputy director of Tisch Cancer Institute
    • Pisters embarks on “listening tour” at MD Anderson
    • Viviane Tabar named chair of the department of neurosurgery at MSK
    • Aradhana Ghosh named vice president of oncology at Syapse
    • NCI awards $16 million grant to PHSU and Moffitt to strengthen tissue bank, reduce health disparities
    • New national clinical trial investigated link between diabetes and pancreatic cancer
    • Mount Sinai’s Sundar Jagannath wins MMRF award
    • AACR urges Congress to reach bipartisan budget agreement
  • Drugs and Targets

    • FDA grants Avastin full approval for glioblastoma
Issue 44 - Nov 28, 2017
  • Caligiuri named president of City of Hope National Medical Center

    Michael Caligiuri was named physician-in-chief of City of Hope and president of City of Hope National Medical Center.

    Caligiuri recently stepped down as director of The Ohio State University Comprehensive Cancer Center and as CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

    He will join City of Hope in this newly created position next February. The appointment was announced on Nov. 28.

  • Conversation with the Cancer Letter

    Caligiuri: It was time for me to hit the refresh button on my career

    After 20 years at Ohio State University, Michael Caligiuri is moving on.

    Caligiuri was named physician-in-chief of City of Hope and president of City of Hope National Medical Center on Nov. 28. He stepped down as director of The Ohio State University Comprehensive Cancer Center and as CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute earlier this month.

  • NCI Director’s Report

    Sharpless lists initial priorities for NCI: Big Data, cell therapy, and more trials at the NIH Clinical Center

    NCI needs to focus on developing a structured approach to Big Data initiatives to ensure optimal use of the institute’s limited resources, said NCI Director Norman “Ned” Sharpless at his first joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors.

  • FDA approves Foundation Medicine’s genomic profiling test for all solid tumors; CMS proposes coverage

    FDA has approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.

    The Centers for Medicare & Medicaid Services—at the same time—proposed coverage of the F1CDx, a laboratory-developed test sponsored by Foundation Medicine.

  • In Brief

    • FDA’s Pazdur named to Bloomberg 50 list
    • National Academies report calls for government negotiation of drug prices
    • Antonio Wolff named chair of ECOG-ACRIN Breast Cancer Committee
    • Louis Weiner to lead MedStar Georgetown Cancer Institute
    • LLS awards $5 million grant to team led by Sylvester’s Stephen Nimer
    • Ronda Henry-Tillman named to Kohn Chair in breast surgical oncology UAMS
    • NCCN, in collaboration with Pfizer, awards nine grants for quality improvement in breast cancer
    • Ronald Maier elected president of American College of Surgeons
    • Leigh Neumayer elected chair of the ACS board of regents
  • Drugs and Targets

    • FDA approves Ogivri, first biosimilar for treating breast and stomach cancers
    • Tesaro receives European approval of Zejula for recurrent ovarian cancer
    • G1 Therapeutics and AstraZeneca enter clinical trials collaboration in NSCLC
    • ITUS Corp. Moffitt enter into CRADA to develop CAR-T technology
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