publication date: Jan. 4, 2019
Issue 1 - Jan. 4, 2019
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  • 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.

Copyright (c) 2018 The Cancer Letter Inc.