20151023 - Oct 23, 2015
ISSUE 39 – OCT. 23, 2015PDF

Pazdur: “The Primary Endpoint of Any Trial Should be the Patient.”


RICHARD PAZDUR and ELLEN GOODMAN were honored by the National Coalition for Cancer Survivorship for their contributions to cancer care at the “Focus on the Care” reception Oct. 21 in Washington, D.C.

Pazdur is the director of the FDA Office of Hematology and Oncology Products, and Goodman is a Pulitzer Prize-winning columnist, author and the founder of The Conversation Project, a national public health campaign focused on end-of-life care.

Goodman received the inaugural Jessie Gruman Award for Patient Engagement, established with a grant from the Center for Advancing Health.


ACS Recommends First Mammogram at 45, Transitioning to Biennial Screening After 55

The American Cancer Society published a breast cancer screening guideline that seems to steer toward the middle course in deciding when mammography screening should start and how often it should be performed.

• The ACS guideline now says 45 is a good age to get the first mammogram. In the past, the society recommended starting at 40. The U.S. Preventative Services Task Force gives a “C” rating to screening before age 50.

• Repeating mammograms every other year after age 55 is acceptable, the society now states. In the past, the society recommended annual mammography screening. USPSTF said screening should be biennial after age 50.

Conversation with The Cancer Letter Wender: ACS Guideline Hinges on Shared Decision Making

The Cancer Letter invited Richard Wender, chief cancer control officer of the American Cancer Society, to describe the rationale for the society’s new guideline for breast cancer screening.

Guest Editorial Brawley on Mammography: What we Know, What we Don’t Know, and What we Believe

By Otis W. Brawley

I have watched the rhetoric and heated debate about screening at age 40, now 45, and 50 for 25 years and am miffed that the discussion consistently ignores the obvious things we can do to save lives.

National Academy of Medicine Elects 80 Members

The National Academy of Medicine elected 80 members during its annual meeting, including at least 17 whose work focuses on cancer treatment and research.

“Our newly elected members represent the brightest, most influential, and passionate people in health, science, and medicine in our nation and internationally,” said Victor Dzau, president of the academy, formerly known as the Institute of Medicine.

Vice President Biden Calls For A National Commitment to Cancer Research Funding

Vice President Joe Biden, in a Rose Garden address announcing his decision to not run for president, called for a national commitment to end cancer—expressing that, were he to run and be elected, it would be a goal of his presidency.

“If I could be anything, I would have wanted to have been the president that ended cancer, because it’s possible,” Biden said Oct. 21. He said that his window of opportunity to mount a winning campaign had closed. “While I will not be a candidate, I will not be silent,” he said.

In Brief

  • Pazdur and Goodman honored by NCCS
  • ACCC announces six winners of 2015 Innovator Awards
  • Jodi Daniel joins Crowell & Moring LLP
  • Kids v Cancer awarded Drucker Prize for Nonprofit Innovation
  • ACCC publishes white paper on integrated health care systems
Drugs and Targets

  • FDA approves Onivyde in metastatic pancreatic adenocarcinoma
  • Yondelis approved for liposarcoma and leiomyosarcoma
  • FDA grants de novo clearance to Sonablate 450 for prostate tissue

CORRECTION: A previous version of last week’s In Brief was unclear in its headline referring to Beth Israel Deaconess cancer center. It has been corrected to say that Manuel Hidalgo was named director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and chief of the Division of Hematology-Oncology at Beth Israel Deaconess Medical Center. Hidalgo will oversee all clinical cancer programs, reporting to Pier Paolo Pandolfi, director of the BIDMC Cancer Center and its Cancer Research Institute.
20151016 - Oct 16, 2015
ISSUE 38 – OCT. 16, 2015PDF

Judge Nixes HRSA’s Second Attempt

To Enact Orphan Drug Discounts in 340B


A federal judge has ruled against the Health Resources and Services Administration over provider access to 340B Drug Pricing Program discounts for orphan drugs.

Judge Rudolph Contreras of the U.S. District Court for the District of Columbia vacated a HRSA “interpretive rule,” in which HRSA sought to make drug companies provide discounts on some uses of orphan drugs.

Contreras determined that Congress specifically excluded all uses of orphan drugs from the 340B program.

340B Guidance to Scale Back Discounts;

Hospitals Will Need to Show Patient Benefit

The 340B Drug Discount Program—designed to help hospitals that serve needy patients—is on the brink of a major revamp.

The Health Resources and Services Administration issued a sweeping guidance that would provide stricter definitions for which patients and entities should be covered (The Cancer Letter, Sept. 11).

The draft guidance, called the 340B Program Omnibus Guidance, was issued Aug. 28. Its public comment period ends Oct. 27.

NCCN Unveils Evidence Blocks as Part of Oncology Guidelines

The National Comprehensive Cancer Network unveiled a new initiative—NCCN Evidence Blocks—in the new versions of the NCCN Clinical Practice Guidelines in Oncology for Chronic Myelogenous Leukemia and Multiple Myeloma.

    Funding Opportunity

    Stand Up To Cancer Offering $7.5 Million in Funding For Early-Career Investigators

    Stand Up To Cancer is making $7.5 million in research funding available to early-career scientists who are pursuing innovative approaches to cancer. Proposals may focus on any discipline within basic, translational, or clinical research.

      In Brief

      • Manuel Hidalgo Named Director of BIDMC Clinical Cancer Programs

      • Alec Kimmelman named chair of radiation oncology at NYU Langone

      • Maciej Lesniak named chair of neurological surgery at Northwestern University

      • Ann Nattinger appointed senior associate dean for research at Medical College of Wisconsin

      • Edward Schaeffer joins Northwestern as chair of urology

      • Peter Kanetsky elected president of American Society of Preventive Oncology

      • IBM acquires Merge Healthcare Inc.

      • American College of Gastroenterology holds first annual SCOPY awards

      • Eli Lilly and Co. to expand its NYC research center

      Drugs and Targets

      • FDA approves Opdivo in non-squamous NSCLC

      • FDA Orphan Designation granted to Blueprint’s BLU-554

      • European Orphan Designations granted to CF102 and ENMD-2076

      • Genentech and Arvinas enter into license agreement

      • Ontario Institute for Cancer Research, Novera, and Janssen to collaborate on small molecule drugs for hematological cancers

      • Eli Lilly and Innovent expand their anti-PD-1 collaboration

      • Sequenom to collaborate with University Medical Center Hamburg-Eppendorf

      • MedImmune joins Human Vaccine Project

      20151009 - Oct 9, 2015
      ISSUE 37 – OCT. 9, 2015PDF

      CT Colonography and Stool DNA

      Fail to Make USPSTF A-List



      CT colonography and stool DNA failed to get on the list of preferred tools for screening for colorectal cancer.

      A draft guideline from the U.S. Preventive Services Task Force released Oct. 6 calls for using one of three strategies:

      • Fecal immunochemical test or high-sensitivity guaiac-based fecal occult blood test every year;

      • Flexible sigmoidoscopy every ten years, plus FIT every year; or

      • Colonoscopy every ten years.

      Capitol Hill

      Collins to Congress: A Flat, Year-long CR Would Be “Devastating” to NIH Research

      If Congress passes another year-long, flat-funding resolution, the effect on NIH “would be simply devastating,” Director Francis Collins told a Senate appropriations subcommittee during a hearing Oct. 7.

      “I can’t emphasize enough how much we are worried about this,” Collins said, sitting alongside NCI Acting Director Douglas Lowy and other institute directors.

        CMS Issues Updated Pricing For Clinical Lab Fee Schedule

        Centers for Medicare and Medicaid Services issued updated pricing determinations for the Clinical Laboratory Fee Schedule, which reversed a payment cut for the Oncotype DX breast cancer test.

          Letter to the Editor from the Coalition for 21st Century Medicine

          Dear Editor,

          We are writing to clarify a few points in your Oct. 2 article, “CMS to Trim Spending on Diagnostic Lab Tests,” as it mistakenly intertwines two issues.

            In Brief

            • Tomas Lindahl, Paul Modrich, and Aziz Sancar win the Nobel Prize

            • Alexander Eggermont’s directorship of Institut Gustave Roussy extended by 5 years

            • Victoria Seewaldt joins City of Hope

            • NYU Langone names Shohei Koide to lead new biologics research program

            • Memorial Sloan Kettering and Cornell University to launch nanomedicine center

            • Oncology Nursing Society launches clinical resource platform

            • SWOG to fund Veterans Affairs Department medical centers

            Drugs and Targets

            • FDA grants breakthrough therapy designation to abemaciclib in breast cancer

            • Merck and Bionomics Ltd. extend collaboration

            • Immunovia and OHSU form pancreatic cancer collaboration

            • MD Anderson and Theraclone Sciences launch OncoResponse company