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Special Report - Sep. 7, 2016
  • NCI’s Moonshot Advisory Panel Identifies Ten Opportunities in Cancer Research

    The Blue Ribbon Panel—a group of experts selected to identify scientific opportunities for the National Cancer Moonshot Initiative—has submitted 10 recommendations to the National Cancer Advisory Board.

    The recommendations include creating tumor atlases and national networks for patient engagement, immunotherapy clinical trials, and data sharing, and supporting research on drug resistance, fusion oncoproteins, symptom management, and development of cancer technologies.

    “The Blue Ribbon Panel recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease,” the authors wrote.

Issue 32 - Sep. 6, 2016
  • AACI, Biden’s Task Force Eye Matching Investors With Projects at Cancer Centers

    The Association of American Cancer Institutes and the White House Cancer Moonshot Task Force are developing a new method for funding research at academic cancer centers through private investment and philanthropy.

    The move promises to establish a mechanism for matching investors with commercially viable research. It appears that this system would work separately from NCI.

  • Amgen to Pay $95 Million to Settle Suit Over Failure to Disclose Aranesp Data

    Amgen Inc. agreed to pay $95 million to settle a class action suit filed by investors who bought the company’s securities between April 2004 and May 2007. 

    The settlement ends a controversy that began on Feb. 16, 2007, when The Cancer Letter reported that Amgen didn’t disclose the results of a study called DAHANCA 10, which tested Aranesp in head and neck cancer patients in Denmark (The Cancer Letter, Feb. 16, 2007).

  • Obituary

    Nobel Laureate Roger Tsien Dies at 64

    Roger Tsien, co-winner of the 2008 Nobel Prize in chemistry and professor of pharmacology, chemistry and biochemistry at University of California San Diego School of Medicine for 27 years, died Aug. 24 in Eugene, Ore. He was 64.

    UCSD officials said Tsien died on a bike trail. The cause of his death hasn’t been determined.

  • Funding Opportunities

    DOD Publishes Instruction for Applying For $120 million in Breast Cancer Program

    The Fiscal Year 2016 Defense Appropriations Act provides $120 million to the Department of Defense Breast Cancer Research Program (BCRP) to support innovative, high-impact breast cancer research to accelerate progress toward ending breast cancer.

  • In Brief

    • Wisconsin wins head and neck SPORE

    • Robert Comis to step down from his position as group co-chair of ECOG-ACRIN Cancer Research Group
    • Jeff Allen named president and CEO of Friends of Cancer Research
    • The American Association for Cancer Research established award in honor of Waun Ki Hong
    • James Morgan named scientific director and executive vice president of St. Jude Children’s Research Hospital
    • Michael Maitland to direct therapeutics for Inova Center for Personalized Health
    • Scripps Health and MD Anderson Cancer Center reached partnership agreement to create Scripps MD Anderson Cancer Center
    • Peyton Anderson Cancer Center joined the Winship Cancer Network
    • Montefiore Health System and SBH Health System agreed to explore a closer integrated relationship
    • The Cancer Prevention & Research Institute of Texas awarded 26 new grants totaling just over $61.5 million
  • Drugs and Targets

    • Novartis and MEI Pharma receive breakthrough therapy designations
    • Exact Sciences Corp. said the Centers for Medicare and Medicaid Services issued an updated Evidence of Coverage notice for Medicare Advantage plans 
    • Biolinerx Ltd. and MD Anderson Cancer Center signed collaboration agreement 
    • Apotex Corp. launched imatinib mesylate tablets
    • Janssen Biotech Inc. submitted supplemental Biologics License Application for daratumumab (Darzalex) to FDA
    • The Department of Pathology at the Icahn School of Medicine at Mount Sinai established the Center for Computational and Systems Pathology
Issue 31 - Aug. 5, 2016
  • MD Anderson (Again) On Top
    of U.S. News and World Report Ranking

    The U.S. News & World Report rankings of the best cancer hospitals for 2016 brought no great surprises. The top four remained unchanged from last year:

    1) MD Anderson Cancer Center

    2) Memorial Sloan Kettering Cancer Center

    3) Mayo Clinic, Rochester, Minn.

    4) Dana-Farber/Brigham and Women’s Cancer Center

    There was a change in the No. 5 slot: UCLA Medical Center. Last year, the Seattle Cancer Alliance and University of Washington Medical Center held that position. MD Anderson placed first nine times in the past 10 years.

  • News Analysis

    The Quantified Impact of Reputation On the U.S. News Best Hospital List

    League tables like those published by U.S. News and World Report should probably be taken with a pinch of salt in any case, but it is the self-marketing of these tables that is just a bit problematic.

    USNWR underlines that “rankings were developed…to help consumers determine which hospitals provide the best care…” and are based on “hard data.” That may be a stretch.

  • An Appreciation

    Gregory Curt, Clinician and Drug Developer, Dies at 64

    Greg Curt died last Sunday. For us in oncology, this one was especially personal. He was a wonderful, generous young man. Greg was a beloved friend and colleague. He was an accomplished cancer researcher and leader in oncology who died of the disease we treat.

    The standard obituary reads that he was born in 1952 in Fall River, Mass. He graduated from Providence College and the University of Rochester School of Medicine. He did residency at New England Deaconess Hospital and a fellowship in medical oncology at the NCI.

  • Nature Editorial Urges Congress To Pass RACE for Children Act

  • In Brief

    • UT Southwestern receives $11 million SPORE grant for kidney cancer program
    • Dana-Farber to get over $100 million for PD-L1 royalty interests
    • University of Pittsburgh Cancer Institute gets NCI preclinical research contract
    • Pierre Massion to direct Vanderbilt-Ingram’s early detection initiative
    • Christopher Manley and Kristen Scully Manley join Fox Chase
    • Natascia Marino named Breast Cancer Research Foundation Investigator at Indiana University
    • Vanderbilt-Ingram receives $3 million grant from Kleberg Foundation
    • Community Oncology Alliance launches Advanced Practice Provider Network
  • Drugs and Targets

    • FDA grants Breakthrough Designation to LEE011 in metastatic breast cancer
    • FDA and CMS to undergo parallel review of FoundationOne genomic assay
    • Advanced Accelerator Applications and NCI form clinical trial agreement
    • Cellectar Biosciences Inc. receives second-phase of NCI SBIR award

    The Cancer Letter will return Sept. 2, after a short publication break

July 2016PDF

 

 

Ovarian Cancer

Niraparib Demonstrates Prolonged PFS in Phase III Trial,
Achieving Primary Endpoint

Niraparib achieved its primary endpoint in a phase III ovarian cancer trial, demonstrating prolonged progression-free survival compared to placebo among patients who are germline BRCA mutation carriers; among patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors as determined by the Myriad myChoice HRD test; and overall in patients who are not germline BRCA mutation carriers.

The trial, NOVA, is a double-blind, international trial that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. There is currently no therapy approved by FDA for maintenance treatment of patients with recurrent ovarian cancer following response to platinum, according to Tesaro Inc., niraparib’s sponsor. Niraparib is an oral, once-daily PARP inhibitor.

 

Breast Cancer

Phase III Trial Rules Out Inferiority of
Trastuzumab Biosimilar ABP 980

Amgen and Allergan plc announced results from a phase III study evaluating efficacy and safety of biosimilar ABP 980 compared with trastuzumab in patients with human epidermal growth factor receptor 2-positive early breast cancer.

ABP 980 is being developed as a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody which targets HER2. The active ingredient of ABP 980 is a humanized monoclonal antibody that has the same amino acid sequence as trastuzumab. ABP 980 has the same pharmaceutical dosage form and strength as trastuzumab in the U.S. and the European Union.

 

Drugs and Targets

 

Colorectal Cancer

 

Lymphoma

 

NCI CTEP-Approved Trials For the Month of July

- Aug. 4, 2016
Special Report - Aug. 1, 2016
  • MD Anderson (Again) On Top
    of U.S. News and World Report Ranking

    The U.S. News & World Report rankings of the best cancer hospitals for 2016 brought no great surprises. The top four cancer centers did not change from last year:

    1) MD Anderson Cancer Center,

    2) Memorial Sloan Kettering Cancer Center,

    3) Mayo Clinic, Rochester, Minn. and

    4) Dana-Farber/Brigham and Women’s Cancer Center.

    There was a change in this year’s No. 5 slot: UCLA Medical Center. Last year, it was the Seattle Cancer Alliance and University of Washington Medical Center

    Though the system used by U.S. News isn’t regarded as scientific, directors of cancer centers and folks in marketing pay close attention to even the smallest of changes in the standing of their institutions.

Issue 30 - Jul. 29, 2016
  • Foundation Medicine Contributes 18,000 Cases to NCI’s Genomic Data Commons

    When the Genomic Data Commons opened June 6, the $20 million portal that consolidates NCI’s datasets contained genomic information from 14,500 patients.

    Before the end of the month, that number jumped to 32,500, as a result of a contribution from Foundation Medicine Inc., a molecular information company founded in 2011.

    The GDC was announced in June by Vice President Joe Biden as part of the National Cancer Moonshot Initiative.

    “We’re adding 18,000 cases from Foundation,” said Louis Staudt, director of the NCI Center for Cancer Genomics. “Many important cancer genes, up to 287, have been sequenced by Foundation in these cases. We applaud their public spirit, and we are really glad that they anted up.”

  • Conversation with The Cancer Letter

    Pellini: Data Sharing Central to Mission At Foundation Medicine

    Making data broadly available to clinicians and researchers has always been a part of the mission for Foundation Medicine Inc., said Michael Pellini, the company’s CEO.

    “We are proud to say the data that we contributed represents an important part of the GDC in terms of its sheer size,” said Pellini, discussing FMI’s decision to contribute 18,000 de-identified patient cases to NCI’s Genomic Data Commons.

  • Conversation with The Cancer Letter

    Staudt: Foundation Medicine’s “Philanthropy of Data” More Than Doubles GDC Portfolio

    Foundation Medicine approached NCI with the idea to make their data useful in the public domain.

    “They had heard through a variety of mechanisms that we were doing the Genomic Data Commons, and they thought this was a good possible fit,” said Louis Staudt, director of the NCI Center for Cancer Genomics. “In the end, it did turn out to be good for both of us.”

    Foundation donated the data from 18,000 de-identified cases, more than doubling the GDC’s total, up to 32,500.

  • Funding Opportunity

    Shire, ACMG Foundation Offering Fellowships in Medical Genetics

    Applications are being accepted for the ACMG Foundation/Shire Laboratory Geneticist Fellowship Awards and Clinical Genetics Residency Program. The program will facilitate 10 one-to-two-year training awards for medical geneticists over the next three years, after a $1.65 million commitment from Shire.

    Applications are available online and will be due in early September for residency programs accredited by the American Board of Medical Genetics and Genomics, beginning in July 2017.

  • Drugs and Targets

    • CHMP issues positive opinion for Onivyde 
    • EMA grants PRIME designation to DNX-2401
    • Mylan and Biocon submit marketing application to EMA for biosimilar Pegfilgrastim
Issue 29 - Jul. 22, 2016
  • Health Centers Limit Reach of Texas Law Allowing Guns on University Campuses

    This may not be the sort of targeted therapy Texas healthcare institutions wish to be known for, but starting Aug. 1, visitors to designated areas at MD Anderson Cancer Center, UT Southwestern, and UT Health Science Center at San Antonio will be able to carry their guns.

    Texas Senate Bill 11, colloquially known as “campus carry,” decrees that “concealed handgun license holders can from now on carry handguns in a concealed fashion at institutions of higher education.”

    Controversy in Texas is fueled by belief of some that gun-carrying, law-abiding citizens are owed the opportunity to defend themselves.

    On the other side of this debate are doctors who—if an MD Anderson survey is an indication—don’t welcome the opportunity to pack heat, and believe that guns would, in fact, make them less safe in the workplace.

  • Conversation with The Cancer Letter

    Weber: We Cannot Completely Ban Guns From MD Anderson’s Campus

    In response to Texas concealed carry laws, MD Anderson proposed a plan that would allow guns only in designated buildings—the rest, specifically areas of worship and hospital facilities, are gun-exclusion zones.

    The UT System Board of Regents approved the cancer center’s recommendations on campus carry July 15.

    “We cannot invoke a policy that explicitly or implicitly bans guns from campus, so the primary message was we are going to follow Texas law,” said Max Weber, associate vice president and deputy chief compliance officer at University of Texas MD Anderson Cancer Center. “I think we sort of fell into this law incidentally…

    “We are a comprehensive cancer center. We are in the business of healing and curing cancer. We’re not a traditional school or university.”

  • Speaking of Guns

    MD Anderson Faculty, Staff Responses to Gun Survey

    MD Anderson surveyed 450 faculty, trainees and staff Sept. 29 through Nov. 10, 2015, to gather their opinions on campus-carry gun laws. Here’s what they said:

    “The American Medical Association has identified gun use and gun violence as a major medical problem in the US. Therefore, it is incumbent upon us as a health care institution to reflect the medical priorities and the values of those of us who have taken oaths to care for the health of others.”

  • BSA and NCAB Approve Three Concepts

    At a June 21 joint meeting, the NCI Board of Scientific Advisors and the National Cancer Advisory Board approved three concepts and deferred one.

  • In Brief

    • UC Santa Cruz receives $2.5 million grant from St. Baldrick’s for Treehouse initiative
    • Susan Pitt receives young investigator award from UW Carbone Cancer Center
    • Charles Simone II named medical director at Maryland Proton Treatment Center
    • Abishek Aphale named assistant professor of dermatology at Fox Chase
    • Rajeswari Nagarathinam joins Fox Chase department of pathology
    • Vy Dinh and Mariana Khawand-Azoulai join Miami Cancer Institute
    • NIH to work with Wondros communications firm for Precision Medicine Initiative
    • Merck to build new campus in Burlington, Mass.
  • Drugs and Targets

    • Health Canada approves Imbruvica in untreated CLL
    • CHMP issues positive opinion for Kisplyx in renal cell carcinoma
    • GlaxoSmithKline and University of Leicester to form collaboration
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
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