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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

        20150710 - Jul. 10, 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

              20150702 - Jul. 2, 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

                    20150626 - Jun. 26, 2015