Issue 28 - Jul 15, 2016
  • New NCI Clinical Trials Program Will Automate Matching Through Third-Party Data Software

    NCI is developing an open-source application intended to make it easier for patients and physicians to get information on clinical trials supported by the institute.

    Vice President Joe Biden endorsed the initiative June 29 at the National Cancer Moonshot Summit in Washington, D.C., saying it will “strengthen participation in cancer research studies to help accelerate medical discoveries and treatments for cancer.”

    When the institute’s application programming interface—a set of routine definitions, protocols, and tools for building software—is completed, data companies and programmers will be able to incorporate information on NCI-sponsored trials into their bioinformatics software. This enables physicians to search NCI’s clinical trials database via a more targeted and intuitive process eventually provided by any third-party software that uses the API.

  • Conversation with The Cancer Letter

    Kibbe: Anyone Can Build Search Interface With Open-Source NCI Clinical Trials API

    Vice President Joe Biden announced a new NCI application programming interface June 29 that will enable third-party developers to connect their bioinformatics software to NCI’s clinical trials database.

    When completed, the API is expected to improve access to the data available from NCI on cancer clinical trials that are supported by the institute.

  • Capitol Hill

    House Committee Approves Spending Bill Cutting Funding for CDC Anti-Smoking Programs

    The House Appropriations Committee approved a bill that would fund the Department of Health and Human Services through 2017, including the NIH, NCI and other related agencies.

    Released last week, the bill includes $161.6 billion in discretionary funding—a $569 million reduction below levels enacted for the 2016 fiscal year. However, the bill increases funding for the NIH by $1.25 billion and the NCI by $264 million.

    The bill contains several provisions to defund implementation of the Affordable Care Act, and prohibits the use of new discretionary funding for the president’s signature health care law. The committee considered more than 30 amendments over two days before approving the bill in a 31-19 vote July 14.

  • Capitol Hill

    Bill Introduced to Mandate Pediatric Clinical Trials

  • Obituary

    Alfred Knudson, Author of Two-Hit Hypothesis, Dies at 93

    Alfred G. Knudson Jr., the creator of the “two-hit hypothesis,” and a director of the Institute for Cancer Research at Fox Chase Cancer Center, died July 10. He was 93.

    The two-hit hypothesis postulates that cancer is produced by accumulated mutations in a cell’s DNA. The hypothesis explains the relationship between the hereditary and non-hereditary forms of cancer, and predicted the existence of tumor-suppressor genes that can suppress cancer cell growth.

  • In Brief

    • NCI announces 13 winners of its Cancer Clinical Investigator Team Leadership Award winners
    • Jeff Boyd receives ovarian cancer research award from the Ovarian Cancer Research Fund Alliance
    • Daniel Shasha joins Northside Radiation Oncology Consultants
    • Michelle Russell-Einhorn joins Schulman IRB
    • Regeneron Pharmaceuticals names three winners of its Regeneron Prize for Creative Innovation
    • American Society for Radiation Oncology elects five officers to board of directors
    • Bonnie J. Addario Lung Cancer Foundation and Van Auken Private Foundation announces team award winners
    • USC Norris and Trovagene to collaborate on liquid biopsy testing
  • Drugs and Targets

    • FDA approves Roche cobas HPV test with BD SurePath specimen vial
    • Health Canada approves Tagrisso in non-small cell lung cancer
    • FDA grants Rare Pediatric Disease Designation to ABT-414
    • FDA grants Orphan Drug Designation to TK216
    • FDA approves premarket supplement application for Novocure’s second-generation Optune system
    • U.K.’s NICE recommends use of Firmagon in prostate cancer
    • Guardant Health and OncoMed Pharmaceuticals to collaborate on custom blood test
    • Eli Lilly and Boehringer Ingelheim to collaborate in metastatic breast cancer
Issue 27 - Jul 8, 2016
  • Conversation with The Cancer Letter

    Stanford Cancer Institute Earns NCI Comprehensive Center Designation

    Stanford Cancer Institute earned the NCI Comprehensive Cancer Center designation, becoming the eighth institution in California to earn this highest level of recognition.

    Nationwide, the number of comprehensive cancer centers now climbs to 47. Earlier this summer, the University of Maryland also received the comprehensive designation.

  • Slamming the Door

    Part XIV: How Al Got It Right 

    Gilman’s resignation enabled him to retain the most precious of all privileges: the ability to look at himself in the mirror.

    By slamming the door loudly and publicly—and by triggering an impossible-to-ignore resignations of scientists who conducted peer review at the Cancer Prevention and Research Institute of Texas—he made it clear that the institute’s scientific review was in danger of being subverted, and that its funds were at risk of being raided by politicians.

    “I built something I am proud of, and now it’s being taken apart,” Gilman said to me at the time. “I can’t work for people who are pushing their own interests at the expense of the interests of cancer patients.

    “A wise and experienced friend said to me: ‘This is always the way it works when you put a large amount of public money on the table. The vultures and the hyenas lie low for two or three years to see how the system really works. And then they come in for their feast.’”

  • Capitol Hill

    House Appropriators Propose $1.25 Billion Budget Increase for NIH in FY 2017

    The House Appropriations Subcommittee on Labor-HHS marked up a bipartisan spending bill July 6 that gives NIH a $1.25 billion increase in the 2017 fiscal year.

    NCI is to receive a $264 million increase over FY 2016.

    The measure boosts the NIH budget to $33.3 billion and now moves to consideration by the full House appropriations committee.

    The Senate Committee on Appropriations June 9 marked up a spending bill, which would provide a $2 billion funding increase for NIH and $216 million increase for NCI in FY 2017.

  • In Brief

    • Mark Socinski named executive medical director of the Florida Hospital Cancer Institute
    • ASTRO names 2016 class of fellows
    • University of Michigan to collaborate with Trovagene Inc.
  • Drugs and Targets

    • European Commission approves Kyprolis in mulitple myeloma
    • FDA grants Fast Track Designation to seribantumab (MM-121) in NSCLC
    • FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device
Issue 26 - Jul 1, 2016
  • News Analysis

    Biden’s Moonshot Goals are Flexible Enough to be Realistic

    After a year of trying to understand the biology and politics of cancer, Vice President Joe Biden admits that he has a stronger grasp on the nuts and bolts of Washington than the evolutionary mysteries known collectively as cancer.

    Hosting the National Cancer Moonshot Summit at Howard University on June 29, Biden delivered a wide-ranging speech, even as his main initiatives remain what they have been from the start of his cancer odyssey:

  • Biden Announces FDA Center of Excellence

    Vice President Joe Biden announced the formation of the FDA Oncology Center of Excellence, which is intended to consolidate the agency’s cancer portfolio and streamline regulatory pathways for cancer-related drugs, biologics, and devices.

    Richard Pazdur, currently the director of the Office of Hematology and Oncology Products, will serve as acting director of the agency’s new cancer center.

    Biden’s June 29 announcement at the National Cancer Moonshot Summit in Washington, D.C. follows months of lobbying by oncology professional societies, advocacy and patient groups.

  • Conversation with The Cancer Letter

    Pazdur Named Acting Director of FDA’s New Cancer Center

    Richard Pazdur, currently the director of the FDA Office of Hematology and Oncology Products, will serve as acting director of the newly formed FDA Oncology Center of Excellence.

    The exact structure, budget and staffing for the program will be determined in an ongoing process, Pazdur said to The Cancer Letter.

    “Because I will be working to develop the structure of the OCE with input across all centers, it would be premature to speculate about what the ultimate structure of the OCE will be,” Pazdur said. “The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center.”

  • Biden: What I Learned About Cancer

    A transcript of Biden’s speech at the National Cancer Moonshot Summit at Howard University.

  • In Brief

    • Haakon Ragde named 2016 Honorary Member of ASTRO
    • Steven Paul elected chairman of Foundation for the NIH
    • Stephen Burley named leader of cancer pharmacology research at Rutgers Cancer Institute of New Jersey
    • Firas Eladoumikdachi named program director at Rutgers Cancer Institute of New Jersey at Hamilton
    • Joel Katz received Spirit of Life Award from City of Hope
    • American Cancer Society plans to double research budget in five years
    • Research!American launches 2016 election blog
    • Mount Sinai and Valley Health System to form partnership
    • IBM Research to collaborate with Melanoma Institute Australia
    • Wistar Institute enters agreement with Christiana Care Graham Cancer Center
  • Drugs and Targets

    • FDA approves Epclusa for chronic hepatitis C
    • FDA grants fourth breakthrough designation to Imbruvica
    • FDA grants fast track designation to TK216 in Ewing sarcoma
    • Hetero launches generic bevacizumab in India
    • Novartis enters into agreement with Xencor
    • OmniSeq receives New York State CLEP approval