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Issue 1 - Jan. 4, 2019
  • Real-World Evidence

    Fulfilling 21st Century Cures mandate, FDA lays out philosophy on real-world evidence—and recruits Amy Abernethy for No. 2 job

    FDA has created a framework for evaluating the use of real-world evidence to support additional indications for already approved drugs as well as to satisfy drug post-marketing study requirements.

  • Conversation with The Cancer Letter

    Amy Abernethy to join FDA as principal deputy commissioner

    Amy Abernethy, a thought leader in the field of evidence generation and the development of real-world evidence, was named principal deputy commissioner at FDA.

    Abernethy, who is now the chief medical officer, chief scientific officer and senior vice president of oncology at Flatiron Health, is expected to start at the agency in February 2019 after leaving Flatiron. She will replace Rachel Sherman, who oversees clinical, scientific, regulatory, and operational medical programs and initiatives across the agency. Sherman is retiring after 30 years of service at FDA.

  • An Appreciation

    Waun Ki Hong, Mentor Magnificus

    (Aug. 14, 1942 – Jan. 2, 2019)

    Yesterday, I received a succession of phone calls through the afternoon and evening—from Roy Herbst, chief of medical oncology at the Yale Cancer Center, Marge Foti, president of the American Association for Cancer Research, Patrick Hwu, head of the Division of Cancer Medicine at the MD Anderson Cancer Center (MDACC), and Otis Brawley, professor of oncology at Johns Hopkins University.

  • An Appreciation

    Waun Ki Hong, eminent role model, was always years ahead of the field

    This week, we lost a cancer research pioneer, and friend and mentor to many in the field, with the sudden death of Waun Ki Hong, M.D., a world-renowned clinical researcher who leaves behind a remarkable legacy.

  • An Appreciation

    A general in BATTLE, Waun Ki Hong was a pioneer of precision medicine

    I was heartbroken to learn of the passing of my mentor, colleague, and friend, Waun Ki Hong. Dr. Hong was the quintessential physician scientist who specialized in all aspects of medicine, but most notably patient care, research, and education. This is a devastating loss for the entire oncology community, and especially for all of the patients he cared for and helped.

  • The 25 most-read stories in The Cancer Letter in 2018

    We thought you might want to see what your colleagues in oncology have been reading. So, we went through our analytics to bring you a list of 25 of The Cancer Letter’s most-read stories of 2018.

  • In Brief

    • Lori Pierce elected ASCO president for 2020-2021
    • Community Oncology Alliance elects new officers and board members
    • José Baselga resigns from position of editor-in-chief of Cancer Discovery
    • BMS to acquire Celgene
    • Moffitt recruits five researchers
  • Funding Opportunities

    ACS and MRA fund $4 million in grants on metastasis in melanoma, other cancers

    The American Cancer Society and the Melanoma Research Alliance have partnered to support research by requesting grant applications involving interdisciplinary teams to better understand and manage metastasis of melanoma and other types of cancer.

  • TCCL Logo

  • Clinical Roundup

    • Study finds elevated risk of rare blood cancers after chemo for most solid tumors
    • Study: Methods for reporting toxicities in cancer trials are falling short
    • Astellas, Pfizer announce positive top-line results from trial of XTANDI in mHSPC
    • G1 Therapeutics announces positive topline results from phase II trial of trilaciclib in SCLC
    • JAVELIN Ovarian 100 trial of avelumab fails to support initial hypothesis
  • Drugs & Targets

    • Lynparza gets FDA approval for first-line maintenance in BRCA-mutated advanced ovarian cancer
    • Sprycel approved in combination with chemo pediatric Ph+ ALL
    • Keytuda approved for recurrent locally advanced or metastatic MCC
    • Merck provides update on Keytruda sBLA for KEYNOTE-042 trial
    • Keytruda receives five approvals in Japan
    • FoundationOne CDx receives regulatory approval in Japan
    • FDA approves longer-acting calaspargase pegol-mknl for ALL
    • GRANITE-001 gets FDA Fast Track for colorectal cancer
  • NCI Trials

    NCI 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 46 - Dec. 14, 2018
  • An Appreciation

    Howard Ozer died as he lived—on a safari

    Around March, my friend Howard Ozer told me he was heading out on a safari. He did these things often, adding to his collection of trophies.

  • Guest Editorial

    Conflicts have killed trust in the system. Advocates must rebuild it

    Breast cancer research is big business. And the incentives in that business are designed to benefit industry, doctors and institutions, leaving patients behind. In 2018 alone, about $1 billion federal dollars were invested in institutions around the country to fund research.

  • In Brief

    • Anil Rustgi named cancer center director at Columbia, New York-Presbyterian
    • Jasmin Tiro to focus on assessing, meeting cancer needs in Dallas/Fort Worth area
    • Leigh Boehmer named medical director of education at the ACCC
    • Pentecost Foundation gifts $3 million to Moffitt
  • TCCL Logo

  • Clinical Roundup

    • Kadcyla cut risk of disease recurrence vs. Herceptin in HER2-positive early breast cancer with residual disease after neoadjuvant treatment
    • BYL719 + fulvestrant improved PFS in PIK3CA mutated HR+/HER2- advanced breast cancer
    • Data show efficacy, tolerability of Kisqali combination in HR+/HER2- advanced breast cancer with visceral disease
    • Insight Genetics launches test for triple negative breast cancer
    • Biotheranostics presents data on the Breast Cancer Index
    • First-line immunotherapy combination fails to improve OS in lung cancer
    • Amifostine delays onset of acute esophagitis for small cell lung cancer patients
  • Drugs & Targets

    • European Commission adopted positive opinion of rucaparib in platinum-based chemotherapy
    • FDA grants orphan drug designation to Merck’s M7824 in biliary tract cancer
Issue 45 - Dec. 7, 2018
  • NCI cuts programs by 5% and non-competing renewals by 3% to maintain paylines in fiscal 2019

    NCI is cutting the budgets of divisions, offices, and centers within the institute by 5 percent to maintain funding for its Research Project Grant pool, which funds a broad range of basic research, as well as clinical trials and health services research.

  • Conversation with The Cancer Letter

    UAB Cancer Center receives $30 million naming gift from O’Neal Industries

    The University of Alabama at Birmingham Comprehensive Cancer Center has received a $30 million gift from O’Neal Industries Inc., a family-owned global business based in Birmingham.

  • In Appreciation

    Lisa Schwartz, expert in overtreatment and pathbreaking educator, dies at 55

    Lisa Schwartz, professor of Medicine and of Community and Family Medicine at Dartmouth Medical School died on November 29 after a seven-year struggle with cancer—a terrible loss to all who knew her.

  • Obituary

    Charles A. Coltman Jr., long-time SWOG chair and co-founder of the San Antonio Breast Cancer Symposium, dies at 88

    Charles A. Coltman Jr., a pioneer of treatment of leukemia and lymphoma, a long-time chair of SWOG, and a co-founder of the San Antonio Breast Cancer Symposium, died after a long illness on Nov. 28. He was 88.

  • In Brief

    • Wafik El-Deiry to lead cancer biology program at Brown 
    • Emory Proton Therapy Center opens
  • TCCL Logo

  • Clinical Roundup

    • Kite announces two-year data for Yescarta in patients with refractory large B-cell lymphoma
    • Kite announces updated data from ZUMA-3 study of KTE-X19 in adult patients with relapsed or refractory ALL 
    • Ibrutinib + rituximab superior to standard treatment for some patients with CLL
    • Data from phase I/II open-label study of BCMA-directed CAR-T cell therapy lcar-b38m show tolerable safety profile, high response and MRD-negative rate in advanced r/r multiple myeloma
    • New long-term data on acalabrutinib in mantle cell lymphoma and CLL
    • Geron announces OS data from IMbark in Imetelstat-treated patients with intermediate or high-risk myelofibrosis and r/r to JAK inhibitor
    • New long-term data on Calquence presented
    • Combination immunotherapy shows high activity against recurrent Hodgkin lymphoma
    • Karyopharm reports positive top-line phase IIb SADAL data for Selinexor in diffuse large B-cell lymphoma
    • Celgene announces initial phase I/II liso-cel data in patients with r/r CLL
  • Drugs & Targets

    • FDA approves Tecentriq + Avastin and carboplatin for initial treatment of specific type of metastatic lung cancer
    • FDA publishes draft guidance on class labeling of in vitro companion diagnostics for classes of drugs in oncology
    • FDA publishes framework document on real-world evidence
  • NCI Trials

    NCI Trials for December

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