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Issue 44 - Dec. 2, 2016
  • House Passes 21st Century Cures Act, Slating $4.8 Billion for NIH, Moonshot

    The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.

  • Just as Feared: House Version of Cures Bill Gives Moonshot Money to NIH Director

    In an unusual move, the National Cancer Advisory Board fired off a letter urging Congress to authorize additional “moonshot” funds, and—just as importantly—to place these new funds in the NCI budget.

    The NCAB letter, dated Nov. 22, was likely motivated by insider accounts of a drive by top NIH officials to intercept these new dollars and place them under the purview of the NIH director (The Cancer Letter, Nov. 4).

  • Letter To The Editor

    Pressures Notwithstanding, MD Anderson Projects Positive Margin in Fiscal 2017

    Dear Editor,

    It was with disappointment that I read the Nov. 4 issue of The Cancer Letter. I feel it is my duty to respond to address inaccuracies that are not only potentially damaging to The University of Texas MD Anderson Cancer Center, but might unnecessarily scare patients who are coming to our institution for cancer care and hope.

  • In Brief

    • Tuveson named director of Cold Spring Harbor
    • City of Hope and Translational Genomics Research Institute to collaborate on precision medicine
    • $50 million to fund prostate cancer research among veterans
    • MSKCC to offer surgery outside Manhattan
    • NCCN guidelines & app help patients combat nausea and vomiting
    • NCCN imaging appropriate use criteria published for 15 guidelines
    • Guardant360 the preferred liquid biopsy test at Northwestern University
    • Dietrick named chief value officer at Chesapeake Urology
    • City of Hope’s Salgia receives 2016 Asclepius Award
    • Southern Research awarded NCI contract
  • Drugs & Targets

    • Darzalex receives FDA approval for multiple myleoma
    • Iclusig receives full FDA approval for CML
    • Athenex and Lilly enter clinical collaboration
    • BMS, Enterome collaborate on microbiome-derived biomarkers
    • First computer-aided detection system gets FDA approval
    • Avelumab accepted for priority review by FDA
November 2016PDF

 

Guidelines

New Evidence-Based Guideline on HER2 Testing for Patients with Gastric Cancer

The College of American Pathologists, the American Society for Clinical Pathology, and the American Society of Clinical Oncology released an evidence-based clinical practice guideline on human epidermal growth factor receptor 2 testing for patients with gastroesophageal cancers.

 

Urothelial Cancer

Phase III Keytruda Study Shows Better OS vs. Chemo for Advanced Urothelial Cancer

Merck announced that the phase III KEYNOTE-045 trial investigating the use of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival.

 

Regulatory Actions

FDA Approves New Indications for Darzalex, Keytruda, Opdivo

Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

 

Multiple Myeloma

Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Skeletal-Related Events

Amgen announced that a phase III study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.

 

Prostate Cancer

 

Testicular Cancer

High-Dose Chemo and Stem Cell Transplant Cures Most Relapsed Testis Cancer

 

Bladder Cancer

Positive Survival Results from Apatorsen Phase II Trial in Metastatic Bladder Cancer

 

Melanoma

 

Immunotherapy

Nektar Phase II Study: Anti-tumor activity in 7/18 evaluable patients with solid tumors

 

NCI CTEP-Approved Trials for November

CCL Nov 2016 - Nov. 29, 2016
Issue 43 - Nov. 18, 2016
  • Republicans Ditch 2017 Appropriations To Tailor Spending to Trump Priorities

    The House and Senate leadership postponed appropriations for fiscal 2017 in favor of a second continuing resolution that runs through March 31, 2017.

    The move Nov. 17 is likely a signal that Congressional Republicans are hoping to start the budget process anew, tailoring it to the priorities of the administration of president-elect Donald Trump.

  • MD Anderson Sues Billionaire Over Using the Word “Moonshot”

    Earlier this year, billionaire Patrick Soon-Shiong created considerable confusion by launching a cancer “moonshot” program at the same time that President Barack Obama announced an initiative that went by pretty much the same name.

    On Jan. 11, a day before Obama announced his program during the State of the Union Address, Soon-Shiong, in a draft press release, claimed that the White House, NIH, FDA and pharmaceutical companies have united to launch the “Cancer MoonShot 2020,” an immunotherapy clinical trials program that Soon-Shiong had designed.

  • In Brief

    • Libutti Named Director at Rutgers Cancer Institute
    • Beau Biden endowed chair established at MD Anderson
    • Feinstein Institute researcher introduces app to help patients with treatment options
    • Cedars-Sinai adds radiation oncology with treatment center
    • Guideline on HER2 Testing for Patients with Gastric Cancer
    • University of Pennsylvania implements tobacco-free campus policy
    • President’s Cancer Panel publishes report on connected health
    • Maintenance of certification points offered through QOPI
  • Drugs & Targets

    • Amgen, Allergan submit application for biosimilar bevacizumab
    • Midostaurin receives FDA priority review
    • Napabucasin granted Orphan Drug Designation