Issue 42 - Nov 11, 2016
  • Conversation with The Cancer Letter

    FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings

    In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.

    Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).

    The scope of this development effort appears to be unprecedented.

  • What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot

    President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.

    Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.

  • Fred Hutchinson Opens Cellular Immunotherapy Clinic

    Fred Hutchinson Cancer Research Center has opened a first-of-its-kind clinic focused on cellular-based immunotherapies for cancer patients in clinical trials.

    The Bezos Family Immunotherapy Clinic will allow researchers to conduct twice as many immunotherapy trials in the next year in pursuit of speeding cures for cancer, officials said.

  • In Brief

    • Peter O’Dwyer elected group co-chair elect of the ECOG-ACRIN
    • Charles Drake joins NY-Presbyterian/Columbia as director of genitourinary oncology. associate director at the Columbia Cancer Center, co-director immunotherapy program.
    • William Cance joins University of Arizona Cancer Center as deputy director
    • Craig Reynolds to retire as as director of the NCI Office of Scientific Operations at Frederick
    • Elisabeth Heath, of Karmanos, receives the Michigan Cancer Consortium’s inaugural Champion Award
    • Felipe Suero joins Department of Anesthesiology at Fox Chase
    • Valierie Armstead joins Fox Chase Cancer Center as professor in anesthesiology
    • Susan Rawl, of Indiana University School of Nursing and IU Cancer Center, receives $2.6M from PCORI for colorectal cancer screening research
    • IU School of Nursing establishes Champion Center for Cancer Control Research, named after Distinguished Professor Victoria Champion.
    • NCCN launches Just Bag It campaign for safe handling of vincristine 
    • Weill Cornell Medicine and New York Genome Center receive a NCI grant worth $490,000-a-year five-year grant for joint cancer genomics data center
    • John Wayne Cancer Institute and Singapore’s Clearbridge BioMedics to establish a circulating tumor cell center
    • St. Baldrick’s Foundation provides infrastructure grants to nearly 40 childhood cancer institutions
  • Drugs and Targets

    • Opdivo receives FDA approval for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
    • Amgen and Janssen Biotech to evaluate combination of Amgen’s Kyprolis and Janssen’s Darzalex in multiple clinical studies in multiple myeloma
    • Hopkins and BMS announce five-year collaboration to study resistance to checkpoint blockers and develop combination immunotherapies.
    • Mylan and Biocon submit BLA for biosimilar trastuzumab
    • FDA has accepts Genentech’s BLA for a subcutaneous formulation of rituximab in blood cancer indications
    • LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
    • Verastem licenses exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib.
    • VENTANA ALK (D5F3) CDx gets FDA approval to use on the VENTANA BenchMark ULTRA automated slide stainer
  • Funding Opportunities

    • SU2C and Genentech form “Catalyst” to provide research funding and access to compounds in effort to find new indications
    • SU2C makes $7.5 million in grants available to early-career scientists focusing on immuno-oncology
Issue 41 - Nov 4, 2016
  • MD Anderson Projects $450 Million Loss in Fiscal 2017

    MD Anderson Cancer Center lost $267.1 million on its operations in fiscal 2016. Now, a month into fiscal 2017, America’s largest cancer center is on track to lose $400 million to $450 million.

    In a confidential report intended for department chairs, MD Anderson’s administration attributes the operating loss to four factors:

    • Epic system (tools, reports, technology fixes);

    • Providers – Capacity (Mondays & Fridays; weekends for select services; services at right location);

    • Demand (wait times, rate of incoming calls/requests to set up appointments);

    • Insurance coverage.

  • Cancer Moonshot Research Dollars Must Go to NCI—Not NIH—Groups Say

    Nearly 50 cancer-related organizations urged Congressional leaders to ensure that funds slated for research in the National Cancer Moonshot Initiative go directly to NCI—as opposed to NIH or any other federal entity.

    The letter, dated Nov. 3, was authored by One Voice Against Cancer, a broad coalition that convenes on national funding and policy issues in oncology.

    “It is … imperative that funding provided for Cancer Moonshot research be specifically directed to NCI,” the letter states.

  • San Antonio’s CTRC Joins MD Anderson Network

    The UT Health Science Center at San Antonio and MD Anderson Cancer Center announced an affiliation to create a cancer care program in San Antonio.

    Under the agreement announced earlier this week, MD Anderson will join forces with the Cancer Therapy & Research Center of the UT Health Science Center.

  • Guest Editorial

    A Countdown: Top 10 Problems With NCI-Designated Cancer Centers

    For nearly a half century, much of the “war on cancer” has been fought at NCI-designated cancer centers, the 69 major medical schools and free-standing research institutes have this designation.

    All the big names are there: UCLA, Stanford, Memorial Sloan Kettering, Dana-Farber, MD Anderson, etc.  The NCI “designates” centers for containing organizational structures that create synergies among cancer researchers.  Designated centers promote multi-disciplinary collaborations, provide scientific tools too expensive for individual laboratories (core resources), incentivize translation of scientific ideas into therapies, etc.

  • In Brief

    • Inova and UVA partnership to establish NCI-designated comprehensive cancer center
    • Eckhardt named director of LIVESTRONG Cancer Institute
    • Kachinc elected president of American Board of Radiology
    • O’Connell receives ACCC Research Award; Presant receives David King Award
    • ASCO and Innovative Oncology Business Solutions collaborate on medical home program
    • UPMC collaborates on radiation therapy center in Ireland
    • Schulman IRB launches central oncology review
    • Engleka joins Burson-Marsteller
    • Cincinnati practice joins US Oncology Network
    • Merck and ACS publish report on Global burden of cancer in women
  • Drugs and Targets

    • Roche receives FDA approval for Tecentriq complementary diagnostic in NSCLC
    • BMS receives Health Canada conditional approval for Opdivo-Yervoy combination
    • Hoffmann-LaRoche’s Alecensaro receives Health Canada approval NSCLC
    • Novogen and Genentech enter in commercialization agreement got glioblastoma multiforme drug candidate
    • NICE recommends Eribulin for locally advanced metastatic breast cancer
Issue 40 - Oct 28, 2016
  • ACA Premiums Up by 25%—Why?

    How Will Oncology Be Affected?

    HHS officials earlier this week announced that health insurance premiums under the Affordable Care Act plans will, on the average, increase by 25 percent next year.

    Experts say that this could be happening at least in part because patients who signed up for the ACA exchanges turned out to be sicker and older than underwriters originally anticipated.

  • Public Health Groups Sue to Force FDA to Mandate Graphic Warnings on Cigarettes

    Eight public health and medical groups filed suit in federal court to force FDA to issue a final rule requiring graphic health warnings on cigarette packs and advertising.

    The lawsuit was filed in Boston by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative, and several individual pediatricians.

  • COA Reports More Attrition of Cancer Clinics

    Since 2008, 1,581 community oncology practices have closed, been acquired, merged, or are struggling to stay open, according to the 2016 Community Oncology Practice Impact Report.

    “An average of 3.6 practices have closed per month since COA began tracking this data,” said Bruce Gould, president and medical director of Northwest Georgia Oncology Centers, and president of the Community Oncology Alliance, in a statement.

  • Drugs and Targets

    • Keytruda Is First Checkpoint Inhibitor To Get Approval for Front Line NSCLC
    • Xtandi Receives FDA Approval for Supplemental New Drug Application
    • YS-ON-001 granted orphan drug designation by FDA
  • In Brief

    • Achilefu Gets DOD Distinguished Investigator Award in Breast Cancer
    • Gov. Andrew Cuomo announced NY-Cuba Partnership for U.S. Clinical Trial of a Cuban Immunotherapy
    • Vanderbilt University Medical Center, Meharry Medical College, and Tennessee State University receive continued federal funding from U54 Partners in Eliminating Cancer Disparities Grants 
    • Grace Lu-Yao joins the Sidney Kimmel Cancer Center at Jefferson
    • Sharon Byers named chief development and marketing officer of the American Cancer Society
    • Emory St. Joseph’s Hospital expands the Winship Cancer Institute
    • Ellen and Gary Davis give $2 million to Weill Cornell Medicine 
    • Varian Medical Systems and McKesson Specialty Health announce a strategic agreement