20150814 - Aug 14, 2015
SPECIAL REPORT – AUG. 14, 2015 

 

MD Anderson Moves from Top-Down Structure

to “Shared Governance” with Faculty Senate

 

MD Anderson Cancer Center was instructed to institute a “shared governance” structure, disbanding its powerful Executive Committee effective Sept. 1.

After years of turmoil and plunging morale, the UT System has instructed the Houston-based cancer center to form a Shared Governance Committee, which would incorporate input from the faculty. The move appears to change the institution’s structure from a strong top-down flow of authority to an unusually democratic system.

The new governance committee will serve as the top advisory body to the institution’s president, Ronald DePinho, and will include all division heads; the chair, chair-elect, and immediate past chair of the Faculty Senate; and senior executives.

The decision was announced Aug. 14, in a faculty-wide email from DePinho and Gary Whitman, chair of the Faculty Senate.

20150807 - Aug 7, 2015
ISSUE 31 – AUG. 7, 2015PDF

Conversation with The Cancer Letter

AstraZeneca Exec Discusses Iressa’s Future in the U.S.

 

After a decade of near-absence from the U.S. market, the AstraZeneca drug Iressa (gefitinib) is back.

The drug, which stayed on the market between 2003 and 2005, when it was pulled because clinical trials in a general population of patients failed to demonstrate a survival advantage, has returned. Now it is accompanied by a diagnostic tests that selects patients.

The Cancer Letter asked Andrew Coop, vice president of US medical affairs in oncology at AstraZeneca, to discuss the company’s plans for the future of Iressa in the US, and lessons that have been learned.

 

Report: Part D Drug Prices “Needlessly High”

Medicare’s Part D program paid significantly higher prices for drugs than either Medicaid or the Veterans Health Administration, a study by Carleton University and Public Citizen found.

Prices paid by Medicare Part D were also above those in 30 other countries.

The price is caused by congressional restrictions on the federal government’s ability to negotiate with the pharmaceutical industry, the study said.

Obituary

Carolyn Kaelin, 54, Dana-Farber Surgical Oncologist and Researcher

Carolyn Mary Kaelin, a surgical oncologist in the Women’s Cancers Program at Dana-Farber and director of the Breast Clinic at Brigham and Women’s Hospital, died July 28, surrounded by loved ones. Kaelin was 54.

FDA News

In Brief

  • Lehigh Valley Health Network joins MSK Cancer Alliance

  • Siteman Cancer Center receives “exceptional” rating from NCI
  • John Cunningham named chairman of pediatrics department at the University of Chicago

  • Jinhgui Zhang named first chair of Department of Computational Biology at St. Jude
  • Stephen Lessnick named director of childhood cancer center at Research Institute at Nationwide Children’s Hospital

  • GI Chair Lopa Mishra to leave MD Anderson Cancer Center

  • Leukemia & Lymphoma Society receives donation from Bristol Myers Squibb

  • Commission on Cancer names Outstanding Achievement Award winners

  • California Dept. of Public Health launches big data collaboration with St. Joseph’s Health

  • Pan-Mass Challenge raises $33.5 million over weekend bike ride for Dana-Farber

 Drugs and Targets

  • Health Canada approves Imbruvica in MCL

  • EMA grants orphan designation to synthetic hypericin
  • AstraZeneca and Heptares Therapeutics enter licensing agreement

  • Mirati Therapeutics and MedImmune launch clinical trial collaboration
 

The Cancer Letter will be taking a short publication break, and will return Friday, Sept. 4.

20150730 - Jul 30, 2015
ISSUE 30 – JULY 31, 2015PDF

Pharma Industry Critics

Seek Grassroots Support

 

Many people are studying the rising prices of cancer drugs. A growing group of oncologists want to do something different: they want to give them a downward push.

Last week, a group of 118 oncologists signed an editorial published in the Mayo Clinic Proceedings in which they laid out seven specific actions that they argue would moderate drug prices.

 

Conversation with The Cancer Letter

The War on Cancer (Drug Prices): Political Education of Hagop Kantarjian

Here is what Hagop Kantarjian has learned over the past two years of his campaign to lower the prices of cancer drugs:

People would rather avoid disputing you head-on.

Instead, they seek to draw you into a process. And as this process drags on, things remain as they are.

Kantarjian, chair of the Department of Leukemia at MD Anderson Cancer Center, is too savvy and too impatient to get sucked into chasing elusive solutions.

Baylor Earns Comprehensive Designation;

Tisch Institute Becomes NCI Cancer Center

The Dan L. Duncan Cancer Center at Baylor College of Medicine and the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai received NCI designations this week.

The Duncan Cancer Center—which was named an NCI-designated cancer center in 2007—was awarded the Comprehensive Cancer Center designation, which includes a $14.56 million, five-year grant. 

Guest Editorial

Kids v Cancer: Laws Need to Catch up to the Science

By Nancy Goodman

Kids with cancer are the last, not the first, to get on trials of promising new drugs. And, when drug companies abandon their unapproved cancer drugs, as they do 95 percent of the time for all sorts of reasons, the chance to study those drugs for kids with cancer goes away forever.

Drugs and Targets

Lenvima Receives FDA Breakthrough Designation

In Brief

  • Thomas Lynch Jr. to step down as director of Yale Cancer Center

  • Peter Schulam to serve as interim center director
  • Karen Reckamp named medical director for clinical research at City of Hope

  • Timothy Lash named leader of cancer prevention program at Winship Institute
  • Ontario Institute for Cancer Research and Centre for Drug Research and Development announces call for pre-proposals for early-stage research

20150724 - Jul 24, 2015
ISSUE 29 – JULY 24, 2015PDF

MD Anderson No. 1 (Again)

In Rankings by U.S. News & World Report

 

MD Anderson Cancer Center has once again assumed its place at the top of the influential U.S. News & World Report rankings for 2015-2016.
The Houston-based center edged out New York’s Memorial Sloan-Kettering Cancer Center.

As MD Anderson returns to the paramount position it has held 11 times over the past 14 years, it does so despite turmoil between its faculty and administration (The Cancer Letter, July 13).

 

 

FDA & NCI Create Unique Jobs Combining Regulatory Science with Clinical Expertise

NCI and FDA are recruiting three medical oncologists who would divide their time between clinical and regulatory duties—half at the FDA Office of Oncology and Hematology Products, and half at the NCI Center for Cancer Research.

These clinician-scientists would serve as associate directors for clinical research at the OHOP, and as independent, tenure-track principal investigators at the CCR.

    In Brief

    • Charles Roberts named director of St. Jude Comprehensive Cancer Center

    • Eric Rohren named chair of radiology at Baylor College of Medicine

    • Carrie Kitko joins Monroe Carell Jr. Children’s Hospital at Vanderbilt
    • Bruce Quinn joins FaegreBD Consulting

    • Children’s Hospital of Philadelphia opens Buerger Center for Advanced Pediatric Care

    Odomzo Approved in Basal Cell Carcinoma

    FDA approved Odomzo (sonidegib) capsules for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Odomzo is marketed by Novartis Pharmaceuticals Corp.

     

    Kyprolis Combination Approved in Relapsed Multiple Myeloma

    FDA approved Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Kyprolis is sponsored by Onyx Pharmaceuticals Inc., an Amgen subsidiary.

       Drugs and Targets

      • FDA grants orphan drug designation to Anisina in neuroblastoma

      • Amgen submits sNDA for Kyprolis for Injection

      • IriSys awarded five-year contact by NCI

      20150717 - Jul 17, 2015
      ISSUE 27 – JULY 17, 2015PDF

      MD Anderson Faculty White Paper Calls for Executive Pay Freeze, Elimination of “Two-Class System”

       

      MD Anderson Cancer Center’s faculty has asked the UT System to freeze the salaries of Ronald DePinho and members of his executive team until they reach a level of parity with faculty salaries, according to a white paper presented to UT System Chancellor Bill McRaven June 14.

      The white paper—authored by the Executive Committee of the Faculty Senate and distributed confidentially to the faculty July 10—is arguably the most comprehensive representation of the faculty’s cumulative dissatisfaction with DePinho and his administration’s performance and handling of personnel matters over the past three years.

       

      Iressa Returns to U.S. Market— Now with Companion Diagnostic

      FDA approved Iressa (gefitinib) for patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

      The drug is being approved concurrently with the therascreen EGFR RGQ PCR Kit as a companion diagnostic.

        NCCS: Covering End-of-Life Planning is a Step Toward Delivering Patient-Centered Care

        Last week, the Centers for Medicare & Medicaid Services announced plans to support Medicare beneficiaries by reimbursing doctors for advance care planning beginning in January 2016.

        The proposed codes would reimburse for discussions about an individual’s wishes, should he or she becomes too ill to make decisions, and for the completion of an advance directive.

        Funding Opportunity

        DoD Taking Applications for $75,000 Horizon Grant

        The Department of Defense is taking applications for its Horizon Award, which offers up to $75,000 in funding to support junior-level scientists to conduct impactful research with the mentorship of an experienced cancer researcher.

        The award is for principal investigators, both pre-doctoral candidates and postdoctoral fellows are eligible, and mentors that have a strong record of funding and publications. The PI and mentor must be from the same organization.

           In Brief

          • Georgetown Lombardi and John Theurer Cancer Center to form research consortium

          • City of Hope establishes professorship with $1.5 million grant

          • Maryann Roefaro named co-chair of COA administrator network

          • Synexus opens three clinical trial research centers in Eastern Europe

          • ACT for NIH appoints seven members to its advisory committee

          Drugs and Targets

          • EU approves Imbruvica in Waldenstrom’s macroglobulinemia

          • FDA grants orphan drug designation to ImMucin in multiple myeloma

          • Cleave Biosciences’s CB-5083 receives FDA orphan drug designation

          • FDA grants fast track designation to Toca 511 and Toca FC

          • FDA grants priority review to MM-398 in pancreatic cancer

          • Eli Lilly and Immunocore launch clinical trial collaboration

          20150713 - Jul 13, 2015
          SPECIAL REPORT – JULY 13, 2015 

          MD Anderson Faculty White Paper to UT Chancellor Calls for Executive Pay Freeze, Elimination of “Two-Class System”

          MD Anderson Cancer Center’s faculty has asked the UT System to freeze the salaries of Ronald DePinho and members of his executive team until they reach a level of parity with faculty salaries, according to a white paper presented to UT System Chancellor Bill McRaven June 14.

          The white paper—authored by the Executive Committee of the Faculty Senate and distributed confidentially to the faculty July 10—is arguably the most comprehensive representation of the faculty’s cumulative dissatisfaction with DePinho and his administration’s performance and handling of personnel matters over the past three years.

          20150710 - Jul 10, 2015
          ISSUE 27 – JULY 10, 2015PDF

          Lilly Drug to Change Squamous NSCLC,

          But ODAC’s Opinion is Nuanced

           

          The FDA Oncologic Drugs Advisory Committee July 9 appears to have recommended approval for the Eli Lilly and Co. agent necitumumab.

          Yes, the word “appears” has indeed appeared in the previous sentence.

          It had to because, in breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of the experimental therapy instead of reducing their answers to a yea or nay vote.

          No vote was taken, but The Cancer Letter’s analysis of ODAC’s discussion suggests that, had a vote been taken, necitumumab would have received an overwhelming 11:1 vote in favor of approval.

           

          Do-It-Yourself Guide to ODAC

          Circle One: Yes, No, Maybe

          FDA has often asked ODAC members to discuss broad scientific questions. However, the approval questions have, without an exception, been shoehorned into the up-or-down dichotomy.

          What is ODAC without a vote on approval questions?

          Here, The Cancer Letter has combined a transcript of the ODAC discussion with a coding scale that may provide a clue about how the vote on necitumumab would have gone.

            Huntsman, UNM Cancer Center, and UT Southwestern Receive NCI Comprehensive Designations

            Three cancer centers have been awarded comprehensive status from NCI, the highest designation possible: the Huntsman Cancer Institute at the University of Utah, UT Southwestern’s Harold C. Simmons Cancer Center, and the University of New Mexico Cancer Center.

            A fourth, the Dan L. Duncan Cancer Center at Baylor College of Medicine, is also expected to receive the comprehensive designation, sources said. This will bring the total number of comprehensive centers to 45.

            House Passes 21st Century Cures Act

            The U.S. House of Representatives July 10 passed H.R. 6, The 21st Century Cures Act without amendments by a 344 to 77 vote.

            The bill—designed to modernize clinical trials and streamline the drug approval process—would boost NIH funding by $1.75 billion in mandatory funding a year over the next five years, for a total of $8.75 billion, and FDA’s budget by a total of $550 million.

              ORIEN Partners with Three Cancer Research Centers

              The Oncology Research Information Exchange Network July 9 announced the addition of three cancer institutions to its precision cancer research partnership, bring the total number of partners to nine.

              The new members are the Rutgers Cancer Institute of New Jersey, the University of Southern California Norris Comprehensive Cancer Center, and Morehouse School of Medicine.

                In Brief

                • Carolyn Britten named director of Hematology/Oncology at the Medical University of South Carolina

                • Marcia McNutt nominated to be president of the National Academy of Sciences

                • Kevin Fitzpatrick named CEO of CancerLinQ LLC

                • Memorial Sloan Kettering Cancer Center to open new lung cancer research center

                • American College of Radiology launches Commission on Patient Experience

                • The Association of Community Cancer Centers launches the Institute for Clinical Immuno-Oncology

                20150702 - Jul 2, 2015
                ISSUE 26 – JULY 3, 2015PDF

                How NCI Will Spend New Money (If it Comes)

                 

                Is new money on the way to NCI? It’s certainly been promised in President Obama’s budget proposal and in the appropriations bills gestating in the House and Senate.

                Those who seek logic in history will read much into timing:

                After a decade of flat funding, decreases and inflationary erosion, the purchasing power of the NIH budget is where it was the year the doubling began in 1999.

                Yet, a cycle this is not. The institute’s 1999 message was “Give us the money and we will use it wisely, because we are the best.”
                In 2015, a leaner, more focused NCI is delivering the more compelling message: “Give us the money and we will give you the cutting edge of precision medicine.”

                 

                Lowy’s First Director’s Report to Advisory Panel

                The following is a transcript of NCI Acting Director Douglas Lowy’s remarks to the joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors, June 24:

                I’m coming to the close of my third month as acting director, and I’d like to give you a status report. It has been really interesting and exciting for me and I can’t thank all of you enough for your incredible support—both my colleagues in NCI, and so many of you extramural colleagues.

                  Senate Appropriators Approve $2 Billion for NIH

                  The Senate Committee on Appropriations June 25 approved the fiscal 2016 Labor, Health and Human Services, and Education Appropriations Bill, which would boost NIH’s budget to $32 billion—an increase of $2 billion above fiscal 2015.

                  The $153.2 billion measure would provide the largest increase NIH has received since the doubling of its budget was completed in 2003.

                  BSA Approves Three Concepts at Joint Meeting with NCAB

                  The NCI Board of Scientific Advisors approved the following concepts at a meeting June 24:

                  • The Non-Communicable Disease Regional Infrastructure Core Planning Grants program seeks to support activities for the planning and designing of sustainable, regional research infrastructure core, established to build, strengthen, and coordinate research and training of non-communicable diseases in low and middle-income countries or regions.

                    The Cancer Letter’s Coverage of Power Morcellation Wins Three Journalism Awards

                    The Cancer Letter won a first place 2015 National Press Club Award in the NPC’s annual journalism competition June 26.

                    The award recognizes Matthew Ong’s series “Power Morcellation: A Hazardous Practice” as the winner in the Newsletter Journalism category.

                      In Brief

                      • Raphael Pollock named surgeon-in-chief for OSU Health System

                      • Jonathan Licht named director of UF Cancer Center

                      • George Wilding named vice provost at MD Anderson Cancer Center 

                      • LIVESTRONG Foundation appoints Donna Palmer and Katie Merrell to leadership team

                      • Cyrus Ghajar receives $4.1 million award from the Department of Defense

                      Drugs and Targets

                      • EMA grants accelerated approval to Opdivo in metastatic melanoma

                      • Leukemia & Lymphoma Society accelerates payment to Celator Pharmaceuticals

                      • Mevion Medical Systems delivers proton accelerator to UH Seidman Cancer Center
                      • Proton Partners International Ltd. acquires site for proton beam therapy center in Wales

                      20150626 - Jun 26, 2015
                      ISSUE 25 – JUNE 26, 2015PDF

                      NIH Receives Glimmer of Hope as AHRQ Inches Closer to Elimination

                       

                      The House and Senate appropriations committees earlier this week passed parallel spending bills that would boost NIH budgets while eliminating the Agency for Healthcare Research Quality, a $465 million agency that plays a central role in the implementation of President Barack Obama’s health care law.

                      After more than a decade of flat funding and budget cuts, both bills provided aggressive increases for NIH:

                      • The House appropriations committee approved a proposed $1.1 billion increase on June 24.

                      • Senate subcommittee appropriators went even further, proposing a $2 billion increase during markup June 23.

                       

                      ASCO Publishes Drug Value Assessment Tool

                      The American Society of Clinical Oncology earlier this week published a proposed framework for assessing the value of new cancer treatments.

                      The paper, published in the Journal of Clinical Oncology June 22, quantifies clinical benefit, side effects and cost as components of value.

                      ASCO’s objective is to build a standardized tool that can be used as the basis of shared decision-making by oncologists and their patients.

                      OHSU Reaches $1 Billion Goal, Begins Recruiting Scientists and Researchers

                      Oregon Health & Science University met the challenge posed by Nike co-founder Phil Knight and his wife Penny by raising $500 million in less than two years, earning the Knights’ matching gift and setting a $1 billion fundraising record. The announcement was made June 25.

                      The $1 billion will support the first large-scale program dedicated to early detection of lethal cancers. OHSU Knight Cancer Institute will now begin rapid recruitment of about 25 of top-tier researchers.

                      Appropriations Bill Seeks to Preempt FDA Efforts to Broaden Tobacco Regulation

                      A $20.65 billion agriculture appropriations bill, which cleared a House subcommittee June 18, seeks to limit FDA’s ability to review electronic cigarettes, cigars and other tobacco products already on the market.

                      The legislation—which was approved by the House Appropriations Subcommittee on Rural Development, Food and Drug Administration and Related Agencies—would prevent the FDA Center for Tobacco Products from requiring products already on the market to go through the Premarket Tobacco Review application process under the Federal Food, Drug and Cosmetic Act.

                        Study: Widespread Overtreatment Of Benign Lung Nodules in Community Oncology Practices

                        Thousands of U.S. patients may be undergoing unnecessary lung biopsies and surgeries annually due to overtreatment of benign lung nodules, according to a study published in the journal CHEST.

                        The study—funded by Integrated Diagnostics, or Indi—examined how community pulmonologists treated and managed the care of 377 patients with indeterminate (medium-sized) lung nodules. The paper is titled “Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study.”

                          Funding Opportunity

                          AACR Launches Grant Program For Young Investigators

                          The American Association for Cancer Research has launched the AACR NextGen Grants for Transformative Cancer Research, a funding initiative to stimulate innovative research from young investigators.

                          The grant mechanism is intended to promote and support creative, paradigm-shifting cancer research that, because of its very nature, may not otherwise be funded through existing channels.

                            In Brief

                            • Five new members appointed to NCAB

                            • Five members rotate off the NCI Board of Scientific Advisors

                            • AHRQ to fund three centers of excellence with $52 million over five years

                            • Maurizio D’Incalci receives award from European Association of Cancer Research, AACR, and Italian Cancer Society

                            • Conquer Cancer Foundation honors six oncology practices with Clinical Trials Participation Awards

                            • Broad Institute to collaborate with Google Genomics

                            • Guardant Health partners with SWOG for NSCLC study
                            • Karmanos Cancer Institute and Detroit Tigers to host “Pink Out the Park”

                             Drugs and Targets

                            • FDA grants priority review to MM-398

                            • Soligenix to recruit patients for phase III study

                            • Advaxis submits special protocol assessment to FDA
                            • Amgen and Roche to collaborate on phase Ib study

                            • Cigna publishes positive coverage decision for VeriStrat

                            20150619 - Jun 19, 2015
                            ISSUE 24 – JUNE 19, 2015PDF

                            Are Cancer Drugs Worth the Money?
                            MSKCC Tool Tests Pricing Rationale

                            A health services researcher at Memorial Sloan-Kettering Cancer Center has proposed a method for assessing whether cancer drugs are rationally priced.

                            Peter Bach, director of the MSKCC Center for Health Policy and Outcomes, constructed DrugAbacus, a tool for analyzing the value of the new generation of cancer drugs.

                            Also:

                            Appropriations

                            House Spending Bill to Eliminate AHRQ While Adding $1.1 Billion to NIH Budget

                            A $153 billion spending bill that cleared a House subcommittee June 17 seeks to abolish the Agency for Healthcare Research and Quality, the federal entity that funds patient-centered outcomes research and monitors the manner in which medicine is practiced in the U.S.

                            At the same time, the bill proposes increasing the NIH budget to $31.2 billion, a $1.1 billion above this year’s level and $100 million more than the White House requested.

                            AAUP Censures MD Anderson

                            MD Anderson Cancer Center has been censured by the American Association of University Professors, an organization that defends academic freedom and shared governance.

                            The decision was made at AAUP’s annual meeting, which concluded June 13 in Washington, D.C. Founded in 1915, AAUP has 47,000 individual members and 300 chapters.

                            Congress Reintroduces Bill to Limit Out-of-Pocket Costs for Oral Anticancer Drugs

                            House and Senate sponsors have reintroduced the Cancer Treatment Parity Act, a bill that would require insurers to provide coverage for oral anticancer drugs on terms no less favorable than coverage for intravenous chemotherapy.

                            Previously introduced in 2011 and 2013, the 2015 version would reduce out-of-pocket costs for oral chemotherapy, but would not mandate coverage of oral medications.

                              CPRIT Reaches Milestone in Providing 2 Million Cancer Prevention Services to Texans

                              The Cancer Prevention and Research Institute of Texas has provided more than 2 million cancer prevention services to Texans across all 254 counties in the state, the institute announced June 16.

                              Prevention measures funded by CPRIT grants include tobacco cessation programs, vaccinations, screening for breast, cervical, and colorectal cancers, genetic testing and counseling, and survivor care.

                                In Brief

                                • John Sampson named chair of Duke Department of Neurosurgery

                                • John Zaia named director of City of Hope’s Center for Gene Therapy

                                • AHRQ to fund three centers of excellence with $52 million over five years

                                • Eli Lilly & Co. announces collaborations with Dana-Farber and Sarah Cannon Research Institute

                                 Drugs and Targets

                                • Gardasil 9 receives marketing authorization from European Commission

                                • FDA approves Ventana ALK (D5F3) CDx companion diagnostic assay for Xalkori