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ISSUE 6 – FEB. 12, 2016PDF



Obama’s $4.1 Trillion Budget Proposes Mandatory Funds for $1 Billion Moonshot

President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

Conversation with The Cancer Letter

Sigal: FDA Should Consolidate Cancer Portfolio

President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence.

The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program, which aims to double progress in cancer research and drug development over the next five years.

Slamming the Door – How Al Gilman Taught Texas a Lesson in Science

Part III: 18,000 Bosses

Between the fall of 2011 and the spring of 2012, I watched MD Anderson from afar, and I didn’t think about CPRIT at all.

Friends who attended early meetings with Ronald DePinho soon after he became MD Anderson’s president said that he was literally grading presentations made to him by faculty members and administrators.

“This was a C-,” he would say.

It was difficult to get a B.

In Brief

  • Miami Cancer Institute joins MSK Cancer Alliance
  • Ramalingam named deputy director of Winship Cancer Institute
  • David McConkey appointed director of Johns Hopkins Bladder Institute
  • Sylvester Comprehensive Cancer Center creates two endowed chairs
  • Pat Keel appointed CFO of St. Jude
  • Paul Vanveldhuisen named COO of The Emmes Corporation
  • American Urological Association, Urology Care Foundation and Chesapeake Urology Associates form partnership
  • Bonnie J. Addario Foundation launches second phase of crowdsourcing challenge
  • ESPN’s Jimmy V Week for Cancer Research raises $3.2 million
Drugs and Targets

  • FDA grants orphan designation to tazemetostat
  • PDS Biotechnology signs CRADA with NCI
  • FDA grants orphan designation to antifungal drug candidate CD101 IV

 

20160212 - Feb. 12, 2016
ISSUE 5 – FEB. 5, 2016PDF



Slamming the Door

Part II: Cancer’s Butt

CPRIT’s review process appeared to have become a major annoyance to those who wanted to redraft the criteria for dispensing the princely sum of $300 million a year. Texas geography and Texas politics did matter—a lot.

The cross-state competition between MD Anderson Cancer Center and UT Southwestern Medical Center proved to be especially important.

MD Anderson has long been a clinical powerhouse, the kind of place you go with a complicated cancer. If it ramped up its basic science, the cancer center would be better positioned to understand the origins of cancer and make more fundamental contributions to treatment of cancers, including discovering useful drug candidates and moving them from the bench to the clinic.

White House Promises $1 Billion for Cancer MoonshotThe White House announced a $1 billion initiative Feb. 1 to jumpstart the national cancer moonshot program—an ambitious proposal first announced by President Barack Obama during his final State of the Union address.

Vice President Joe Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the program, which aims to achieve a decade’s worth of progress within the next five years.

FDA Releases New Opioid Plan as Senators Stall Robert Califf’s Confirmation as Commissioner

Robert Califf, the nominee to serve as the next FDA commissioner, and other FDA leaders called for a broad plan to reassess the agency’s approach to prescription opioid medications. The move comes as Senators block a vote on his confirmation for the top post.

Sen. Edward Markey (D-Mass.) and Democratic presidential candidate Sen. Bernie Sanders of Vermont have both placed procedural holds on Califf’s confirmation, citing the agency’s policies and methods for approving opioids, as well as Califf’s financial ties to the pharmaceutical industry.

In Brief

  • Lonial named head of hematology and oncology at Winship Cancer Institute
  • Stand Up To Cancer Canada announces brain cancer dream team
  • Keith Hanson McGregor named CEO of ESMO
  • M. Beatriz Currier joins Miami Cancer Institute
  • H. Benjamin Harvey and Courtney Moreno receive ACR fellowship
  • Van Andel Research Institute-SU2C Dream Team trial enters phase II
Drugs and Targets

  • Venetoclax receives third FDA breakthrough designation
  • FDA tells Telesta they need another phase III MCNA trial
  • Mayo Clinic collaborates with Morphotek in triple-negative breast cancer study.
20160205 - Feb. 5, 2016
January 2016PDF

 

Melanoma

Phase III Trial Binimetinib Increases PFS in NRAS-Mutant Melanoma vs. Dacarbazine

Array BioPharma reported top-line results from the ongoing phase III clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, demonstrating that the study met its primary endpoint of improving progression-free survival when compared with dacarbazine treatment.

The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm (HR=0.62, 95% CI 0.47-0.80, p < 0.001). Binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in the RAS/RAF/MEK/ERK pathway.

Breast Cancer

Survey of Breast Cancer Cell Function Identifies New Drug Uses, Combinations

Researchers conducted a large analysis of breast cancer cell function, saying the results suggest dozens of new uses for existing drugs, new drug discovery targets, and new drug combinations.

“This study represents the largest survey yet of how the genetic changes in breast cancer cells interfere with pathways critical to their growth and survival, pathways that might be targeted by combinations of new or existing drugs,” said lead study author Benjamin Neel, director of the Perlmutter Cancer Center at NYU Langone Medical Center.

The study results were published in the journal Cell. The researchers combined genetic analyses of more breast cancer cell types than studied previously, new statistical methods, and comparisons with databases of molecular signatures and the effects of anti-cancer drugs.

Ovarian Cancer

Trial of 200,000 Women Shows Screening Can Reduce Mortality by 20 Percent

One of the largest randomized trials ever has concluded that ovarian cancer screening may reduce ovarian cancer mortality by an estimated 20 percent after follow up of up to 14 years, but researchers say longer follow-up is needed to determine the ultimate mortality reduction and if screening the general population is cost effective.

The United Kingdom Collaborative Trial of Ovarian Cancer Screening enrolled 202,638 women, aged 50-74 years, between 2001 and 2005 through 13 trial centers in England, Northern Ireland and Wales. The study results were published in The Lancet.

The study tested the hypothesis that screening for ovarian cancer in the general population can reduce disease mortality without significant harm, in line with screening programs for other cancers.

Colorectal Cancer

Cervical Cancer

Analysis Evaluates Moore Criteria for Bevacizumab Effectiveness

NCI CTEP-Approved Trials for the Month of January
Drugs and Targets

  • Opdivo-Yervoy combination granted accelerated approval in metastatic melanoma
  • Halaven approved for unresectable or metastatic liposarcoma
  • Zepatier approved for chronic hepatitis C
  • Health Canada grants conditional approval to Blincyto in Ph- acute lymphoblastic leukemia
  • FDA grants breakthrough designations to BI1482694 (HM61713) and venetoclax
  • Priority review granted to lenvatinib in renal cell carcinoma
20160201 - Feb. 1, 2016
ISSUE 4 – JAN. 29, 2016PDF



Slamming the Door

How Al Gilman Taught Texas A Lesson in Science

Alfred Gilman’s approach to distributing public funds wasn’t particularly difficult to understand: he wanted to pay for the best science available. Period.

The pot of money entrusted to Gilman was vast. In 2007, Texas voters approved the largest investment in cancer research outside the federal government: $3 billion, to be spent over 10 years. By way of comparison, NCI grants going to Texas researchers and institutions added up to $240 million a year. CPRIT more than doubled that money. Only Texans were eligible to apply.

Gilman accepted the CPRIT job at age 68, because he thought that it would be a significant contribution to a major research effort, and a nice way to finish out a long career.

Sixty-Nine Cancer Centers Urge HPV VaccinationIn an unprecedented move, 69 NCI-designated cancer centers have come together to advocate for HPV vaccination as a preventive measure against many HPV-related cancers.

“HPV vaccination is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities,” the centers said in a consensus statement published Jan. 27. “The HPV vaccine is cancer prevention.”

PCORI Passes $1.2 Billion in Total Research Funding

The Patient-Centered Outcomes Research Institute approved $70 million for nine new patient-centered research projects focused on conditions including ductal carcinoma in situ, diabetes, chronic lung disease and migraines.

With these latest awards, PCORI has now approved or awarded more than $1.2 billion in research funding.

In Brief

  • Minesh Mehta named deputy director at Miami Cancer Institute
  • Carmen Solórzano named chief of Division of Surgical Oncology at Vanderbilt
  • Judy Keen named ASTRO director of scientific affairs
  • Tara Yates joins Wistar Institute as director of communications
  • Ovarian Cancer National Alliance and Ovarian Cancer Research Fund merge
  • UC San Diego Health selects e+CancerCare to operate Chula Vista radiation center
  • Harvard Business School launches Precision Trials Challenge
Drugs and Targets

  • FDA expands Opdivo-Yervoy Label with accelerated approval in melanoma
  • Halaven approved for unresectable or metastatic liposarcoma
  • Zepatier approved for treatment of chronic hepatitis C
20160129 - Jan. 29, 2016
ISSUE 3 – JAN. 22, 2016PDF



Biden’s Cancer Moonshot to Focus
On Bioinformatics and Data Sharing

The Obama administration will find the money to create a comprehensive oncology bioinformatics system, Vice President Joe Biden pledged Jan. 19 at a meeting of international cancer experts at the World Economic Forum in Davos-Klosters, Switzerland.

Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the White House “moonshot” program, which was announced by President Barack Obama during his final State of the Union address Jan. 12 (The Cancer Letter, Jan. 15).

Obama is expected to announce the details of funding the moonshot in his budget proposal Feb. 9.

 Biden: Cancer Moonshot Seeks Quantum Leaps, Not Incremental Change

The text of Vice President Joe Biden’s Jan. 19 remarks at a World Economic Forum meeting of international cancer experts in Davos-Klosters, Switzerland, follows:

Almost everyone in the world, as you all know, has a family member who’s had cancer. Every year, around the world, 14 million people are diagnosed with cancer and 8 million people succumb to it, die, from cancer.

And like many of you, I have experienced in my family the dreaded C-word that I think is the most frightening word that most people—as these docs and scientists can tell you—that anyone wants to hear walking out of a doctor’s office.

     

    Guest Editorial

    The False Allure of The Cancer Cure

    By Robert Cook-Deegan

    Over the past century, we have had many wars on cancer, and now we have a national “moonshot” to be spearheaded by Vice President Joe Biden, announced in President Barack Obama’s Jan. 12 State of the Union Address.

    In 1937, even as Congress was establishing the National Cancer Institute as the first of the National Institutes of Health, the American Committee to Combat Cancer was organizing the “Women’s Field Army” to mobilize against cancer, especially uterine, ovarian, and breast cancers. The main argument was that the nation was spending vastly more per person affected, and per death, on polio than it was on cancer. It was framed as a war.

      In Brief

      • James Willson named chief scientific officer of CPRIT

      • Mary-Claire King wins the Szent-Györgyi Prize for Progress in Cancer Research

      • Mylin Torres named director of Glenn Family Breast Center at Winship
      • New York Genome Center receives $100 million grant from the Simons Foundation and Carson Family Charitable Trust

      • MD Anderson Cancer Center and AbbVie form immuno-oncology collaboration

      Drugs and Targets

      • Venetoclax receives Breakthrough Therapy Designation from FDA

      • FDA grants Priority Review to lenvatinib

      20160122 - Jan. 22, 2016
      ISSUE 2 – JAN. 15, 2016PDF



      Obama Announces Moonshot to Cure Cancer

      President Barack Obama announced a moonshot aimed at curing cancer, a project to be led by Vice President Joe Biden.

      The United States can do “so much more,” Obama said in his seventh and final State of the Union address Jan. 12. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources they’ve had over a decade.

      “Tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us, on so many issues over the past 40 years, I’m putting Joe in charge of mission control. For the loved ones we’ve all lost, for the family we can still save—let’s make America the country that cures cancer once and for all.”

       When Moonshots Collide

      Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

      Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

      Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

       Conversation with The Cancer Letter

      Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

      Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

      In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

      Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

      USPSTF Recommends Biennial Mammography Screening For Women Ages 50-74

      The U.S. Preventive Services Task Force published its final recommendation statement on screening for breast cancer, delivering a B rating for mammography screening every two years in women between ages 50 and 74.

      The task force also recommended selectively offering mammography to women below age 50, saying that the decision to begin that screening should be an individual one. The USPSTF gave this age group a C recommendation.

      “Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years,” the task force wrote in its recommendations.

       Campaign for Tobacco-Free Kids Demands Recall of Gold Standard Accreditation of U.S. Chamber of Commerce

      The Campaign for Tobacco-Free Kids said the U.S. Chamber of Commerce is undeserving of its Gold Standard accreditation by the CEO Roundtable on Cancer, saying it should be rescinded because of the trade group’s lobbying efforts against tobacco regulations.

      In Brief

      • Leonard Zon receives Knudsen cancer genetics award from NCI
      • Amy McKee named acting deputy office director at FDA OHOP
      • Paul Kluetz appointed associate director of clinical science at FDA OHOP
      • Dean Tsarwhas named medical director at Northwestern Medicine Lake Forest Hospital
      • Rafat Abonour named medical liaison for the International Myeloma Foundation
      • Ravi Salgia joins City of Hope as chair of Department of Medical Oncology
      • FASEB publishes recommendations for research reproducibility
      • COA elects new board and executive committee members
      Drugs and Targets

      • Blincyto receives conditional approval from Health Canada
      • FDA grants priority review to venetoclax in CLL
      • Sorrento Therapeutics and Karolinska Institutet form collaboration
      • Eisai submits MAA to European Medicines Agency for lenvatinib
      • MD Anderson and DelMar Pharmaceuticals form collaboration
      • Debiopharm International SA collaborates in EORTC trial
      20160115 - Jan. 15, 2016
      ISSUE 1 – JAN. 8, 2016PDF



      Ellen Stovall, Pioneering Advocate For Survivorship, Dies at 69

      Ellen Stovall, one of the most respected and knowledgeable cancer advocates in Washington, died Jan. 5.

      The cause of death was a heart attack.

      Stovall, 69, was first diagnosed with Hodgkin’s lymphoma in 1971. Her disease recurred in 1983. In 2007, she had bilateral mastectomies due to the late effects of the radiation treatment. Her heart disease and chronic pain were also attributed to her original treatment.

      “Ellen is a rare transformational figure in cancer care, who saw an enormous unfilled need and led the development of the entire concept of cancer survivorship,” said Norman Coleman, head of the Experimental Therapeutics Section and associate director of the NCI Division of Cancer Treatment and Diagnosis, and senior medical advisor at the HHS Office of the Assistant Secretary for Preparedness and Response.

      Nobel Laureate Alfred Gilman,
      Defender of Good Science, Dies at 74

      Alfred G. Gilman, a Nobel laureate who concluded his academic career in the role of chief scientific officer of the Cancer Prevention and Research Institute of Texas, died Dec. 23, 2015. Gilman, 74, had pancreatic cancer.

      Gilman shared the 1994 Nobel Prize in Physiology or Medicine with Martin Rodbell of the National Institute of Environmental Health Sciences for their discovery of G proteins—guanine nucleotide-binding regulatory proteins. G proteins are central to signaling transduction, the process of receiving signals from outside the cell and activating a range of cellular responses.

      G proteins are found in nearly all cells, and are central to body processes that include vision, smell, hormone secretion, and thinking in humans. Problems in G-protein signaling contribute to a range of diseases, including cholera, whooping cough, and cancer.

      Cancer Death Rate Continues Steady Drop

      Steady reductions in smoking combined with advances in cancer prevention, early detection, and treatment have resulted in a 23 percent drop in the cancer death rate since its peak in 1991, according to the annual Cancer Statistics report from the American Cancer Society.

      The drop translates to more than 1.7 million cancer deaths averted through 2012. The findings were published in CA: A Cancer Journal for Clinicians. The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the United States in 2016.

      Lab-Developed Tests

      AMP Responds to FDA Report On Regulation and Oversight

      The Association for Molecular Pathology responded to the FDA’s call for oversight of laboratory developed tests, rebutting 20 case studies published by the federal agency that illustrated possible harms inflicted on patients when laboratories did not follow FDA requirements.

      The AMP said the agency’s collection of case studies “grossly misrepresents the public health concerns of laboratory developed testing procedures,” and said that FDA oversight would likely prevent few of the potential patient harms.

      In the case of clinical trials performed at Duke University using a faulty genomics predictor to assign cancer treatment to individual patients, the AMP said that that test did not cause patient harm, and was not used in a clinical setting.

      Funding Opportunity

      AACR and Bayer Offering Research Grants

      The American Association for Cancer Research and Bayer announced the 2016 AACR-Bayer Innovation and Discovery Grants program for meritorious projects that examine novel targets and biomarkers in oncology research.

      In Brief

      • St. Jude to open new Graduate School for Biomedical Sciences
      • Research!America unveils 2016 policy wish list
      • Memorial Sloan Kettering opens outpatient surgery center
      • Inova and George Mason University form research partnership
      • St. Jude receives $20 million commitment from Steven & Alexandra Cohen Foundation
      Drugs and Targets

      • FDA grants Breakthrough Therapy Designation to Boehringer Ingelheim TKI Inhibitor in NSCLC
      • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
      • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix
      20160108 - Jan. 8, 2016
      December 2015PDF

       

       Multiple Myeloma

      Head-to-Head Phase III Study Demonstrates Kyprolis Nearly Doubles PFS over Velcade

      Results from the phase III head-to-head ENDEAVOR study comparing Kyprolis to Velcade in patients with relapsed multiple myeloma showed that patients treated with Kyprolis achieved progression-free survival of 18.7 months compared to 9.4 months (HR=0.53; 95% CI: 0.44, 0.65; p<0.0001).

      The findings demonstrated that patients treated with Kyprolis (carfilzomib) plus dexamethasone lived twice as long without disease worsening as those treated with Velcade (bortezomib) plus dexamethasone.

      Also:

       Leukemia

      AML Patients Receiving PKC412 Midostaurin Show 23% OS Improvement in Phase III Trial

      Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.

      In the phase III RATIFY clinical trial, the median OS for patients in the PKC412 treatment group was 74.7 months (95% CI: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group.

      The trial evaluated the addition of either PKC412 or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 or placebo as a single agent for up to one year.

       Drugs and Targets

      FDA Approves Opdivo Injection for Renal Cell Carcinoma Patients

      FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

      In the CheckMate-025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis. In the study, the safety profile was consistent with prior Opdivo studies.

      Also:

      Pancreatic Cancer

       Liver Metastases

      Phase III Melphalan Trial Shows Improvement in Hepatic-PFS in Melanoma Patients

      20151225 - Dec. 25, 2015
      ISSUE 46 – DEC. 18, 2015PDF



      How Medical Devices Do Harm

      Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.

      Enemies—who are great in number—call him much worse.

      Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.

      Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.

      Two Docs Who Broke the Code

      Hooman Noorchashm sends out several scathing emails each day.

      Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”

      “The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”

      His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.

      “Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.

      The Root Causes of Harm From Medical Devices

      The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator.

      These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about 350 patients undergoing hysterectomies and myomectomies.

      It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick (R-Pa.) wrote in a Dec. 18 letter to the agency.

      Conversation with The Cancer Letter

      Vodra: 510(k) Process Does Not Assess Risk; Needs to Be Broken Up Into Multiple Risk Groups

      FDA’s Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.

      Instead, the 510(k) process relies on “substantial equivalence” to predicate devices, thereby allowing subsequent iterations of a device to introduce risk without active FDA surveillance.

      “A huge variety of devices are now in Class II, and they pose extraordinarily different kinds of risk,” Vodra said. “The current test for clearance of a 510(k) is, ‘Is the proposed device substantially equivalent to another device (the predicate device or device chain) that has been marketed?’ “The answer may be yes, but that does not tell you much about risk of the proposed device or its predicates.”

      Pilot: Don’t Change 510(k), Put More Money Into Enforcing Reporting Laws

      Patients are being harmed because FDA doesn’t commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA’s 510(k) device clearance process.

      There is no need to revamp the 510(k) process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes.

      “It’s a good system we have now, but FDA needs to allocate more resources to enforcement, especially for user facilities,” Pilot said. “That’s why FDA, with its authority, and this opportunity to put the emphasis on reporting to the user facility required by law, and then by specific regulation, should be going for money penalties for user facilities that do not abide by the reporting requirement.”

      Daniel: FDA Does Not Have a Reliable Surveillance System for Medical Devices

      Devices aren’t tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.

      “Without having such a data system that can be used for active safety surveillance—i.e., safety monitoring that doesn’t rely on reporting of adverse events by providers or manufacturers—it is challenging to quickly identify potential safety issues with devices early on,” Daniel said.

      Capitol Hill

      Congress Passes $1.1 Trillion Omnibus Bill

      Boosting NIH Budget by $2 Billion

      Congress passed a $1.1 trillion government spending bill Friday morning, increasing the NIH budget by $2 billion. The measure now moves to the president’s desk for approval.

      Editorial

      The Year in Review

      As the New Year approaches, we are preparing to revamp our website and launch an app. The work on it is almost done—a January launch seems likely.

      In 2015, we got to report some cool stories, win national journalism awards and successfully deflect Amgen’s attack on our First Amendment rights.

      In Brief

      • Raymond DuBois named dean of MUSC College of Medicine
      • John “Drew” Ridge elected medical staff president at Fox Chase – Temple Health
      • Bhramar Mukherjee appointed associate director for population science at University of Michigan Comprehensive Cancer Center
      • Joseph Smith Jr. awarded Huggins Medal from the Society of Urologic Oncology
      • Society of Toxicology honors award recipients, including Richard Adamson with the Founders Award
      • Albert Einstein Cancer Center awarded NIH grant
      • OHSU and Cancer Research UK to collaborate on early detection
      • St. Jude opens proton therapy center
      • IU Simon Cancer Center taking high school and college applicants for its Summer Research Program
      • HealthWell Foundation launches fund for underinsured multiple myeloma patients
      Drugs and Targets

      • FDA approves Bendeka injection, a bendamustine formulation for infusion
      • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
      • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix

       

      The Cancer Letter will take a publishing break and return Jan. 8, 2016.

      20151218 - Dec. 18, 2015
      ISSUE 45 – DEC. 11, 2015PDF



      Core Grants of Newer, Smaller Centers

      Slated to Get Immediate Funding Boost

      NCI is implementing a less draconian formula for increasing the core grants of newer cancer centers.

      The plan, which was unveiled at the Dec. 1 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board, seeks to correct an acknowledged inequity: by virtue of being in the NCI program longer, more established cancer centers had more incremental increases, thus amassing larger core grants.

      In a unanimous vote, BSA asked for some refinements to the plan, but seemed to be fine with its main features.

      An earlier version of the plan called for fundamental changes in the funding formula, which—according to NCI modeling—would have reduced the core grants of some of the older, larger cancer centers and gave these funds to the newer centers.

      Capitol Hill

      NIH Looks For $1-2 Billion Raise in FY 2016

      As Congress Approaches Another Deadline

      NIH is slated to receive a $2 billion increase under the Senate appropriations bill, but only $1.1 billion under the House plan for the current 2016 fiscal year.

      The Senate version would bring NIH finding up to $32 billion, with NCI receiving $5.204 billion. The House version would total just above $31 billion for NIH, including $5.081 billion for NCI.

      Both chambers of Congress are setting aside $200 million for the Precision Medicine Initiative, which would include $70 million for NCI.

      Guest Editorial

      The Academic Difference

      By George J. Weiner

      Academic cancer centers have a major and unique role to play in enhancing cancer research, clinical care and education. This role will increase in value as our understanding of the complexity of cancer grows and is applied to care of patients.

      Academic cancer centers leverage synergies among these various missions, with the result being a positive impact on patient health and the economy at the local, regional and national levels. Accelerating progress in cancer medicine is dependent on the success of academic cancer centers and development of new models of collaboration between academic cancer centers and community oncology.

      ACS and ASCO Jointly Publish Breast Cancer Survivorship Guideline for Primary Physicians

      The American Society for Clinical Oncology and the American Cancer Society published a joint guideline for primary care physicians on managing the long-term care of breast cancer survivors, recommending regular surveillance for recurrence, but not performing laboratory or imaging tests in patients not displaying symptoms.

      In Brief

      • Carlos Rodriguez-Galindo to lead St. Jude’s international outreach
      • Daniel Simon named president of UH Case Medical Center
      • Terrill Jordan named president and CEO of Regional Cancer Care Associates
      • Gustave Roussy institute recruiting young doctors
      • Baylor to collaborate with Biocept on blood-based cancer tests
      Drugs and Targets

      • FDA grants accelerated approval to Alecensa for ALK-positive NSCLC patients
      • FDA approves Vistogard for emergency treatment of certain chemotherapy overdoses
      • FDA clears cooling cap for preventing hair loss during chemotherapy
      • EMA grants orphan designation ot Debio 1143
      • Amgen submits expanded application for Kyprolis in the EU
      • AstraZeneca and Voluntis to test digital support service in ovarian cancer trials
      • Eli Lilly and Merck to collaborate on abemaciclib-Keytruda phase I trial
      20151211 - Dec. 11, 2015