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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.
20151023 - Oct. 23, 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

      20151016 - Oct. 16, 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

            20151009 - Oct. 9, 2015
            ISSUE 36 – OCT. 2, 2015PDF

            CMS to Trim Spending on Diagnostic Lab Tests

            The Centers for Medicare and Medicaid Services appear to be executing a two-step strategy to shrink the $8 billion annual price tag of clinical diagnostic laboratory tests.

            On Sept. 25, CMS released a final payment determination for the Clinical Laboratory Fee Schedule that cuts payment by over 90 percent for some tests.

            One of the industry leaders, Genomic Health, saw payments for Oncotype DX breast cancer tests drop by 15 percent, and a 79 percent drop for its colon cancer test. The determination involves a set of nine codes for advanced diagnostic laboratory tests.

            Guest Editorial

            Local Medicare Contractors Bring Chaos to CMS Coverage of Next Generation Tests

            By Dane Dickson

            Yesterday, two Medicare administrative contractors—National Government Services and Cahaba Government Benefit Administrators—released draft local coverage determinations for next generation sequencing in advanced lung cancer.

            The NGS LCD covers the initial diagnosis of lung cancer and Cahaba’s LCD covers patients who have been re-biopsied to test for additional mutations that may have been missed on testing of the initial biopsy by older technology.

              BMS Combination Approved in Melanoma;

              Dana-Farber Challenges BMS Patent Rights

              A combination of two Bristol-Myers Squibb immuno-oncology agents—Opdivo (nivolumab) and Yervoy (ipilimumab)—received an accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

              The Oct. 1 announcement marks the first time FDA has approved a combination regimen of two immuno-oncology agents in cancer—both drugs had previously been approved as monotherapies for the same indication.

                Capitol Hill

                Congress Averts Shutdown, Funds NIH Through December

                Congress passed a continuing resolution Sept. 30—averting a shutdown—that will fund the federal government at current levels through Dec. 11.

                Funding for both NIH and NCI dipped slightly as part of a 0.21 percent cut to all non-defense discretionary agencies.

                  USPSTF Speaks on its Role In the Affordable Care Act

                  The U.S. Preventive Services Task Force published a viewpoint in the Journal of the American Medical Association to clarify how their recommendations are linked to the Affordable Care Act coverage mandate—and how they believe clinicians, payers, and the public should interpret their recommendations.

                  The viewpoint, titled “Evidence-Based Clinical Prevention in the Era of the Patient Protection and Affordable Care Act: The Role of the US Preventive Services Task Force,” describes how some have misinterpreted task force grades of C or I as recommendations against screening or even against coverage.

                    Funding Opportunity

                    Pershing Square Sohn Cancer Research Alliance Prize For Young Investigators

                    The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research.

                      In Brief

                      • Richard O’Reilly to step down as chair of pediatrics at MSKCC

                      • James Wade named deputy director at Inova cancer institute

                      • MSKCC’s Lorenz Studer named MacArthur Fellow

                      • Three investigators named winners of the Paul Marks Prize

                      • Kesari joins Providence Saint John’s Health Center

                      • Turaga named endowed professor in sarcoma research at Medical College of Wisconsin

                      • Jan Schluchter named CCO at Myriad Genetics GmbH

                      • Stand Up to Cancer Canada Dream Team members announced

                      • Center to Advance Palliative Care publishes state-by-state report card
                      Drugs and Targets

                      • FDA grants accelerated approval to Keytruda in NSCLC

                      • EMA CHMP grants two positive opinions to Kyprolis and Blincyto

                      • FDA grants priority review to defibrotide for hepatic VOD

                      • Aspen Park acquires Ohio State’s APP-111

                      • UbiVac and Janssen form collaboration

                      • City of Hope and Sorrento Therapeutics form LA Cell Inc.

                      20151002 - Oct. 2, 2015
                      September 2015PDF


                       Lung Cancer

                      Avastin Biosimilar Meets Phase III Endpoints, Demonstrating Clinical Equivalence

                      Amgen and Allergan plc. announced positive top-line results from Avastin biosimilar candidate ABP 215, which met its primary and secondary endpoints in a phase III trial in advanced non-squamous non-small cell lung cancer.

                      ABP 215 is being developed as a biosimilar to Avastin, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.

                      The primary endpoint, objective response rate, was within the prespecified margin for ABP 215 compared to Avastin (bevacizumab), showing clinical equivalence.

                       Neuroendocrine Tumors

                      Afinitor Extends PFS by 7.1 Months in Gastrointestinal and Lung NETs

                      Novartis announced results of a phase III study showing Afinitor (everolimus) tablets reduced the risk of progression by 52 percent (HR=0.48; 95% CI, 0.35-0.67; p<0.00001) compared to placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin.

                      The study, RADIANT-4, was presented at the European Cancer Congress in Vienna, Austria.

                      Additionally, the data show Afinitor, a mammalian target of rapamycin (mTOR) inhibitor, extended median progression free survival by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.23-13.3) in the Afinitor arm and 3.9 months (95% CI, 3.58-7.43) in the placebo arm.


                       Prostate Cancer

                      Additional Analyses Show Custirsen Lowered Serum Clusterin Levels in CRPC Patients

                      OncoGenex Pharmaceuticals Inc. presented results from additional exploratory analyses of the phase III SYNERGY trial, demonstrating that custirsen treatment significantly lowered serum clusterin levels from baseline in men with metastatic castrate-resistant prostate cancer.

                      The data, presented at the 2015 European Cancer Congress in Vienna, Austria, showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes.

                      Myeloid Malignancies

                      Two NEJM Papers Evaluate Imetelstat in Myelofibrosis and Essential Thrombocythemia

                       Bladder Cancer

                      Cyramza Increases PFS In Phase II Study of Patients Who Failed Platinum Therapy

                       NCI CTEP-Approved Trials For the Month of September
                       Drugs and Targets

                      • FDA Approves Varubi for CINV
                      • FDA Grants Priority Review for MCNA in invasive bladder cancer
                      • FDA Grants Priority Review to Kyprolis in relapsed multiple myeloma
                      20151001 - Oct. 1, 2015
                      ISSUE 35 – SEPT. 25, 2015PDF

                      Information Blocking by E-Health Record Firms Threatens CancerLinQ, ASCO Says 

                      Congress must put an end to the emerging practice of “information blocking” by demanding that electronic health records are able to exchange data in an “interoperable” fashion, the American Society of Clinical Oncology urged at a congressional briefing.

                      At the briefing Sept. 15, ASCO said that some EHR companies are erecting obstacles that preclude the sharing of data contained in patient health records.

                      Baselga: Why I Believe NIH is On Threshold of the Largest Budget Increase in 12 Years

                      As congressional leaders discuss potential ways to avert a government shutdown, which could happen in less than a week if policymakers are unable to agree to a short-term continuing resolution to keep the government running beyond Sept. 30, I remain optimistic that NIH will receive its largest annual budget increase in 12 years.

                      After 12 years of flat funding, a significant number of members of Congress on both sides of the aisle are enthusiastically backing the NIH, which is the largest supporter of medical research in the world. Many in Congress, Republicans and Democrats alike, appear to be singing from the same song sheet about the importance of prioritizing the NIH budget.

                        In Brief

                        • UNC, Vanderbilt get “exceptional” scores for Cancer Center Support Grant renewal applications

                        • Peter Schultz named CEO, Steve Kay named president of The Scripps Research Institute

                        • Jeffrey Medin named MACC Fund Endowed Professor at the Medical College of Wisconsin 

                        • Evelyn Whitlock named chief science officer at Patient-Centered Outcomes Research Institute

                        • Joaquin Espinoza named associate director of science at the Linda Crnic Institute for Down Syndrome
                        • Robert Schreiber, Philip Greenberg named editors-in-chief of Cancer Immunology Research
                        • Christoph Zielinski named editor-in-chief of ESMO Open
                        • Huntsman Cancer Institute becomes first Mediso Preclinical Imaging Center of Excellence in North America
                        • SCIEX announces collaboration with Fred Hutchinson on targeted proteomics
                        • Experimental Therapeutics at Mount Sinai team up with Regeneron on antibody research
                        • Thomas Jefferson and GenomOncology co-developing cancer profiling system
                        • Gilda’s Club Chicago, cancer organizations launch metastatic breast cancer awareness campaign
                        • The Ride to Conquer Cancer raises $2.1 million for cancer research
                        Drugs and Targets

                        • FDA approves Varubi for chemotherapy-induced nausea

                        • Roche NimbleGen introduces enhanced whole exome sequencing solution for medical and translational research

                        • CTI BioPharma Corp. plans to submit NDA for pacritinib

                        • Amgen Inc. and Xencor Inc. enters immunotherapy research agreement

                        20150925 - Sep. 25, 2015
                        ISSUE 34 – SEPT. 18, 2015PDF

                        A New Doubling: Advocates, NCI Seek 7% Boost for Medical Research Funding

                        NIH, NCI and FDA should receive budget increases of at least 7 percent a year, the 2015 Cancer Progress Report by the American Association for Cancer Research recommends.

                        The NCI Bypass Budget for 2017, published almost simultaneously with the AACR report, requests a series of annual 7-percent increases for NCI, which over a decade would double the institute’s budget. 

                        NCI Bypass Budget Calls for 7% More in 2017—and Doubling by 2026

                        The NCI Bypass Budget for 2017 asks for a 7-percent increase over fiscal 2016, followed by a series of annual 7-percent increases that would continue through 2026, when the institute’s budget would double.

                        The Bypass Budget is submitted by the NCI director to the U.S. President under a unique authority given to NCI under the National Cancer Act of 1971. Over the years, the budgets have had different functions, which reflected the priorities—and styles—of the institute directors who submitted them.

                          Lowy: Increase for Cancer Center Grants Is Contingent on FY2016 Appropriations

                          NCI is planning to increase funding for the Cancer Center Core Grants, Acting Director Douglas Lowy said to the National Cancer Advisory Board at a meeting Sept. 16.

                          “Whatever we do, I’m not going to talk about the FY16 budget, but I just want to point out that it has not been passed, and until it is passed and until we get an increase in our appropriation, we would need to hold in abeyance the commitment for full funding for the increases in order to be fiscally responsible,” said Lowy during his second director’s report since he became acting director.

                          Robert Califf Tapped for FDA Commissioner Position

                          President Barack Obama nominated Robert Califf to the post of Commissioner of Food and Drugs.

                          Earlier this year, Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency. Califf, 63, is an expert in cardiology, clinical research, and medical economics.

                          NCI Funds Five Teams to Work with Animal Models for Children’s Cancer

                          NCI has funded five research teams to participate in its Pediatric Preclinical Testing Consortium.

                          The consortium is designed to focus on preclinical models in order to help prioritize agents for entry into clinical trials.

                          In Brief

                          • Jones, Parwani recruited to key roles in Ohio State Wexner pathology programs

                          • Broad Institute, MD Anderson Cancer Center designated as Genome Characterization Centers

                          • Robin Davisson named president and CEO-elect of Melanoma Research Alliance

                          • MD Anderson and Esperance Pharmaceuticals enter strategic alliance

                          Drugs and Targets

                          • AbbVie submits sNDA for Imbruvica in CLL Patients

                          • FDA grants fast track designation to Can-Fite BioPharma Ltd.’s liver cancer drug 
                          • FDA accepts Wellstat Therapeutics’ NDA for treatment of chemotherapy overdose

                          • FDA and the European Medicines Agency accepts regulatory applications for Gilotrif
                          • AstraZeneca and Peregrine Pharmaceuticals enter into immunotherapy clinical trial collaboration

                          • ICON teams up with IBM to reduce time and costs of drug development
                          20150918 - Sep. 18, 2015
                          ISSUE 33 – SEPT. 11, 2015PDF

                          What’s in a Suffix?

                          FDA’s Dilemma: How to Name Biologics


                          After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.

                          Zarxio (filgrastim-sndz), sponsored by Sandoz Pharmaceuticals, a unit of Novartis, appeared on the U.S. market Sept. 3, offering a lower-priced alternative to the branded product, Neupogen.

                          With biosimilars about to appear on the market, FDA is preparing to reconsider the manner in which these agents—as well as the reference products they copy—are named.


                          HRSA Publishes Long-Awaited 340B Mega-Rule

                          The Health Resources and Services Administration issued the long-awaited “mega-rule” intended to define who qualifies for deep discounts on drug prices under the federal 340B program.

                          Established in 1992 to benefit hospitals and clinics that serve low-income and uninsured patients, the 340B Drug Pricing Program has expanded exponentially in recent years.

                          GAO to Investigate Power Morcellation Harms

                          The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.

                          The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.


                          Gianni Bonadonna, 81, Pioneering Researcher

                          Gianni Bonadonna, 81, a pioneering cancer researcher whose work focused on Hodgkin’s lymphoma and breast cancer, died Sept. 7.

                          His death was announced by the Istituto Nazionale Tumori of Milan.

                          Bonadonna research included the initial studies on the clinical efficacy of adriamycin (doxorubicin), epirubicin and bleomycin; a number of seminal trials on adjuvant and primary chemotherapy for high-risk breast cancer; as well as a combined modality for the treatment of Hodgkin’s disease—in 1972, he designed a new combination of drugs known as ABVD: adriamycin, bleomycin, vinblastine and dacarbazine.

                          CVS Marks First Anniversary Of Stopping Tobacco Sales

                          CVS Health marked the first anniversary of ending tobacco sales at its CVS/pharmacy locations, and released study data showing a reduction in cigarette purchases over the past year.

                          The company also announced a joint initiative between CVS Health and Scholastic to launch a school-based tobacco-prevention program.

                          70th Annual Lasker Awards Go To Witkin, Elledge, Allison, Medecins Sans Frontieres

                          The 70th annual Lasker Awards went to: Evelyn Witkin and Stephen Elledge for basic medical research; James Allison for clinical research; and Medecins Sans Frontieres for public service.

                          The awards carry an honorarium of $250,000 for each category, and will be presented Sept. 18 in New York City.

                          In Brief

                          • Chad Mirkin wins first Sackler Prize from the National Academy of Sciences

                          • Arteaga and Alt awarded scientific prize by the American-Italian Cancer Foundation
                          • Herbert Fritsche receives award from International Society of Oncology and Biomarkers

                          • Trovagene launches European Trovagene Research Institute
                          Drugs and Targets

                          • FDA grants Priority Review to Alectinib in lung cancer

                          • Janssen and Alligator Bioscience enter agreement
                          • Sequenom to collaborate with UC San Diego

                          • Vaccinogen enters agreement with Dublin City University over DiCAST
                          • OICR and Structural Genomics Consortium make drug prototype available to the research community

                          • PhRMA publishes report on U.S. drugs in development
                          20150911 - Sep. 11, 2015
                          ISSUE 32 – SEPT. 4, 2015PDF

                          UT Chancellor Mandates Unprecedented Shared Governance Structure at MD Anderson


                          After years of turmoil and plunging morale at MD Anderson Cancer Center, the UT System took what observers describe as an unprecedented step—forming a Shared Governance Committee.

                          The new structure, instituted Sept. 1, disbands the once powerful Executive Committee, thereby changing the cancer center’s top-down power structure.

                          The new governance committee is designed to incorporate input from the faculty, and serve as the top advisory body to the institution’s president, Ronald DePinho.



                          Judge: Amgen Can’t Depose Cancer Letter Reporter (Me)

                          A federal judge ruled that Amgen Inc. cannot force me to answer questions related to a 2007 story that sparked a class action suit by investors and triggered a change in FDA regulations of erythropoiesis-stimulating agents.

                          Judge Amit Mehta, of the U.S. District Court for the District of Columbia, quashed a subpoena filed by Amgen that sought information related to my reporting of a story about a critically important clinical trial showing that patients who received Aranesp did worse than patients who did not.

                          NCI-MATCH Trial Opens

                          ECOG-ACRIN opened the NCI-MATCH precision medicine trial, the largest, most scientifically rigorous precision medicine trial in cancer to date.

                          NCI-MATCH seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.

                          ASCO Updates Policy on Genetics and Genomic Testing

                          The American Society of Clinical Oncology issued an updated policy statement on genetic and genomic testing for cancer susceptibility.

                          Published in the Journal of Clinical Oncology, the statement reviews the ways in which new technologies are transforming the assessment and identification of inherited cancer susceptibility, and makes a series of recommendations for the optimal deployment of these technologies in oncology practice.


                          UNMC’s Sidney Mirvish, 86

                          Cancer researcher Sidney Mirvish died at age 86. His research into nitrosamines and carcinogenesis led to changes in the way lunch meats, hot dogs and sausages were made.

                          Mirvish served as professor emeritus in the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center, where he was faculty member for 46 years. Mirvish died due to complications following emergency surgery on Aug. 18.

                          In Brief

                          • Edith Mitchell named president of National Medical Association

                          • Robert DiPaola, Stephen Gruber, and Candace Johnson named to AACI Board of Directors
                          • NIH Director Francis Collins awarded Leadership in Personalized Medicine Award

                          • Massimo Cristofanilli named associate director for precision medicine at Northwestern University Lurie Cancer Center
                          • Jeffrey and W. Kimryn Rathmell appointed to leadership roles at Vanderbilt University Medical Center

                          • Lois Travis named director of survivorship research program at Indiana University Simon Cancer Center

                          • Rachel Humphrey named chief medical officer of CytomX

                          • Donald Sheldon appointed regional president at University Hospitals

                          • Keith Perry named chief information officer at St. Jude

                          • Northwestern Medicine names breast cancer OncoSET program

                          • CPRIT awards seven grants, totaling $23 million

                          Drugs and Targets

                          • FDA approves Varubi for CINV

                          • European Commission grants authorization to Unituxin for pediatric neuroblastoma
                          • FDA grants Orphan Designation to Toca 511 and Toca FC

                          • FDA grants Orphan Designation to MTG-20
                          • FDA grants Priority Review to MCNA

                          20150904 - Sep. 4, 2015
                          August 2015PDF



                          High-Risk Subset of CLL Patients Shows Benefit in Phase II Trial

                          A statistically significant percentage of chronic lymphocytic leukemia patients in a phase II clinical trial responded to venetoclax therapy.

                          The open-label study, sponsored by AbbVie, met its primary endpoint, achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion, according to an independent review analysis.

                          The study enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.

                          The primary efficacy endpoint is overall response rate, and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings.


                          Lung Cancer

                          Atezolizumab Immunotherapy Meets Response Endpoint in Phase II NSCLC Study

                          A phase II study of atezolizumab immunotherapy met its primary endpoint, shrinking tumors in patients with locally advanced or metastatic non-small cell lung cancer whose disease expressed PD-L1.

                          The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine.

                          The study, BIRCH, is an open-label, multicenter, single-arm study that evaluated the safety and efficacy of atezolizumab in 667 people. Results from the study will be presented at an upcoming medical meeting, according to the drug’s sponsor, Genentech, a member of the Roche Group.



                          Drugs and Targets

                          European Commission Approves Unituxin in Pediatric High-Risk Neuroblastoma

                          The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.

                          Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin.

                          The European approval was based on demonstration of improved event-free survival and overall survival in a multicenter, open-label, randomized trial (ANBL0032) sponsored by NCI under a Cooperative Research and Development Agreement with the drug’s sponsor, United Therapeutics Corp., and conducted by the Children’s Oncology Group.


                          Liver Cancer

                          ThermoDox plus RFA Increase OS By 58 Percent in HEAT Study


                          Carcinoid Syndrome

                          Oral Telotristat Etiprate Trial Meets Phase III Primary Endpoint


                          NCI CTEP-Approved Trials for the Month of August

                          20150831 - Aug. 31, 2015
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