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ISSUE 27 – JULY 4, 2014PDF



Harvard Physician, Whose Cancer Was Spread Through Morcellation, Seeks to Revamp FDA Regulation of Medical Devices

On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.

Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.

Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.

Conversation with The Cancer Letter
Challoner: We Recommended FDA Replace 510(k) Clearance

The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.

The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.

Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process. 

photoBertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.

“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”

photoBSA Approves Trial of Carbon Ion Therapy, Extends EDRN and Provocative Questions

Question: What’s more expensive than proton beam radiation therapy?

Answer: Carbon ion radiation therapy.

With CIRT centers costing about $300 million to construct—about twice as much as proton beam centers—the potential adoption of this technology threatens to further inflate health spending worldwide.

photoIn Brief

  • Li Ma and Jeffrey Tyner receive Wachter Award from AAAS

  • John Cleveland named associate director of basic science at Moffitt Cancer Center

  • The Community Oncology Alliance appoints new officers

  • Roswell Park Cancer Institute receives “outstanding” distinction from NCI

  • The American Society for Radiation Oncology names 30 new fellows

20140704 - Jul. 3, 2014
June 2014PDF

Non-Small Cell Lung Cancer

Pooled Analysis of Two LUX-Lung Trials Shows Prolonged Survival with Afatinib

New overall survival data of two phase III clinical trials, LUX-Lung 3 and LUX-Lung 6, demonstrated that patients with advanced non-small cell lung cancer whose tumors have the most common epidermal growth factor receptor mutation lived longer if treated with first-line afatinib compared to chemotherapy. 

In the pooled analysis, afatinib (Gilotrif) prolonged survival of lung cancer patients whose tumors have common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 to 24.3 months) and significantly reduced the risk of death by 19 percent (HR=0.81, p=0.037). 

Also:
Prostate Cancer 
Enzalutamide Reduced Risk of Progression By 81 Percent in Metastatic Prostate Cancer

A drug used to treat men with late-stage prostate cancer proved effective in stemming progression of the disease in research participants who had not yet received chemotherapy and extended their survival, according to results from a multi-national phase III clinical trial 

An analysis of the study’s results, published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology annual meeting in Chicago, found that participants treated with enzalutamide saw an 81 percent reduction in the risk the cancer would progress and a 29 percent reduction in the risk of death. 

Pancreatic Cancer
Vaccine and LDCT Pretreatment Can Help PDACs Become Vulnerable to Immunotherapy

By priming pancreatic ductal adenocarcinomas with a therapeutic vaccine and a low-dose chemotherapy combination prior to surgery, researchers converted PDACs into cancers that may respond to immunotherapy.

Researchers pretreated PDAC patients with the vaccine GVAX and low doses of the chemotherapy cyclophosphamide, which caused the aggregation of immune cells inside the patients’ tumors, and many of these immune cells expressed proteins that may make these cancers amenable to immunotherapies such as PD-1 inhibitors.

The trial was published in Cancer Immunology Research, a journal of the American Association for Cancer Research, produced in collaboration with the Cancer Research Institute).

Leukemia
Ibrutinib Increases OS, PFS Versus Ofatumumab in Phase III
Multiple Myeloma
Phase III PANORAMA-1 Trial Meets PFS Primary Endpoint
Thyroid Cancer
Phase III Trial Data: Lenvatinib Extends PFS by Over 14 Months
Glioblastoma
Vaccine Increases PFS by 4 Months In Phase II Per-Protocol Analysis
NCI Approved Trials for the Month of June
FDA Approvals

  • Lymphoseek label updated to include head and neck squamous cell carcinoma

  • Aloxi injection approved for preventing chemotherapy-related nausea in children as young as one month old

  • Orphan drug designation granted to mocetinostat for myelodysplastic syndrome

  • Invenia ABUS breast imaging technology approved 

20140630 - Jun. 30, 2014
ISSUE 26 – JUNE 27, 2014PDF



ODAC Clarifies Standards for Maintenance In Ovarian Cancer;
Nixes Olaparib in 11-2 Vote

Some of the questions that landed the AstraZeneca drug Olaparib (lynparza) before the FDA Oncologic Drugs Advisory Committee were classic:

• How much progression-free survival is enough?

• Can you make use of post-hoc analysis to identify a cohort in which the drug appears to be most effective?

Two big questions in their own right, but in the case of Olaparib, these questions were even more important because of the setting. Olaparib is intended as maintenance for relapsed ovarian cancer, where the standard of care is no cancer drugs at all.

Joint NCAB-BSA Meeting
NCI Prepares for Intramural Program Review

NCI has received some relief from sequestration, and the budget cuts will be adjusted proportionally, Director Harold Varmus said at the joint meeting of the National Cancer Advisory Board and the Board of Scientific Advisors June 23.

“The FY 14 budget is not very dissimilar from last year’s budget,” Varmus said. “We had relief from sequestration. We have correspondingly reduced the level of cuts we have imposed on both competitive and non-competitive awards. We expect to be awarding roughly the same number of RPGs, research project grants, as we did in FY 13.”

photoGroups Urge FDA to Take More Action Against Tobacco Products

On the fifth anniversary of the landmark 2009 law granting the FDA authority over tobacco products, 10 leading public health and medical organizations called on the FDA and the Obama Administration to prioritize three actions to reduce tobacco use.

photoIn Brief

  • James Downing named CEO of St. Jude Children’s Research Hospital

  • Lynda Chin receives fellowship at MD Anderson Cancer Center

  • Thomas Hansen, CEO of Seattle Children’s, to retire in 2015

  • Cornelia Ulrich and Bruce Edgar to join Huntsman Cancer Institute

photoFDA News

  • Lymphoseek label updated to include head and neck SCC

  • Aloxi injection approved to prevent chemotherapy-related nausea and vomiting in children as young as one month old

  • Fast Track status granted to DNX-2401 in glioblastoma

  • Orphan Drug status granted to mocetinostat for myelodysplastic syndrome

20140627 - Jun. 27, 2014
ISSUE 25 – JUNE 20, 2014PDF



Partnership Points to New Path Forward For Drug Approval and Clinical Research

SWOG earlier this week started to accrue patients to Lung-MAP, a clinical trial for second-line treatment of non-small cell lung cancer.

The trial, also called Lung Cancer Master Protocol or SWOG S1400, uses the patients’ tumor characteristics to select one of five targeted therapies, comparing them with active control in each arm. 

Lung-MAP is funded by a public-private partnership, which combines NCI’s limited funds with those of commercial sponsors, pointing to a new way of pooling resources to conduct faster, more efficient registration trials. 

Conversation with The Cancer Letter
What $34,000 per Patient Buys in Lung-MAP

The Cancer Letter asked David Wholley, director of research partnerships for the Foundation for the National Institutes of Health, to explain the novel scientific and administrative structure of Lung-MAP.

“For the first five drugs that are going into the trial, NCI is putting in about $24 million, and companies are putting in about $55 million. This would cover the costs for all of the drugs to complete testing through phase III,” he said.

photo90-Ton Cyclotron Delivered To University of Maryland, Touching Off D.C.-Area Proton Radiation Competition

BALTIMORE—Constructed in Germany, shipped to the port of Baltimore, and driven through downtown during the night, the 90-ton cyclotron arrived at the University of Maryland’s Proton Treatment Center.

photo340B Drug Discount Program
HRSA Defends Orphan Drug Rule

Cancer survivors face higher medical costs and productivity losses when compared to people without a cancer history, according to a CDC study published June 13. 

photoIn Brief

  • Patricia LoRusso named associate director of innovative medicine at Yale Cancer Center

  • Corrine Augelli-Szafran named director of chemistry at Southern Research Institute

  • Sandeep Reddy named chief medical officer of Caris Life Sciences

  • Hiromitsu Ota receives award from Wistar Institute

  • Yeshiva University and Montefiore Health System agree on new management structure for Albert Einstein College of Medicine

  • Dana-Farber Cancer Institute and Trovagene Inc. begin collaboration

  • Eli Lilly and Qiagen announce plan to co-develop assay panels

  • Bayer Pharma AG and arGEN-X collaborate to develop therapeutic antibodies

20140620 - Jun. 20, 2014
ISSUE 24 – JUNE 13, 2014PDF



Judge’s Order Likely to Derail Federal Rule Clarifying 340B Drug Discount Program

Many people love the 340B Drug Pricing Program. 

Hospitals, clinics and cancer centers rely on it to buy drugs at discounts as deep as 50 percent—and then collect reimbursements that don’t reflect the discount. 

Many others hate 340B, arguing that the federal program gives qualified providers an unfair advantage, and making it even more difficult for office-based oncology practices to survive. 

Guest Editorial
OHSU’s Brian Druker on Accelerating the Pace of Scientific Progress

We are facing a disturbing paradox in science. We have unprecedented potential for advancements spurred by current technologies. But at the same time we are confronting flat to declining funding. 

This climate provides a unique opportunity to examine and improve how we fund research. 

photoGroups Organize Capitol Hill Push for Lung Cancer Screening

The Centers for Medicare and Medicaid Services have another six months to decide whether to cover low-dose computed tomography screening. Yet, proponents of screening seem unwilling to take the chance that Medicare coverage would be restrictive.

To tilt the scale in their favor, they have launched two congressional sign-on letters to CMS.

photoCancer Survivors Face Greater Economic Burdens, Study Says

Cancer survivors face higher medical costs and productivity losses when compared to people without a cancer history, according to a CDC study published June 13. 

photoAs Cigars Gain Popularity Among High School Boys, Legacy Urges FDA Regulation

The number of high school boys who smoke cigars—16.5 percent—is now on par with cigarette use, said the Centers for Disease Control and Prevention.

photoIn Brief

  • Kraft named director of University of Arizona Cancer Center

  • St. Jude redesignated as an NCI Comprehensive Cancer Center

  • AstraZeneca CAMCAR, S.A. partners with Cancer Genetics Inc.

  • Memorial Sloan Kettering forms collaboration with Quest Diagnostics

  • Merck signs agreement with Sysmex Inostics GmbH

  • ASCO publishes suvivorship compendium

  • International health organizations publish guidelines for establishing cancer registries

  • Association of Clinical Research Professionals coordinator designation recognized by ANCC Magnet program

  • The Cancer Letter receives the 2014 Dateline Award for Excellence from the Society of Professional Journalists

20140613 - Jun. 13, 2014
ISSUE 22 – MAY 30, 2014PDF


DePinho Explains Tenure Decision,
Professors Dispute Key Details

Confronted with the prospect of censure by an academic freedom group, Ronald DePinho, president of MD Anderson Cancer Center, is defending his decision to deny tenure renewal to two faculty members.

Responding to an inquiry by the American Association of University Professors, DePinho said that his critics are incorrect in asserting that his administration gave no formal explanation for denying tenure renewal to two faculty members.

photoDePinho’s Letter to the AAUP

Responding to an inquiry by the American Association of University Professors, MD Anderson Cancer Center President Ronald DePinho said his critics are incorrect in asserting that his administration gave no formal explanation for denying tenure renewal to two faculty members.

photoBoyd’s Rebuttal

Douglas Boyd, a professor at MD Anderson, sent his own letter to the American Association of University Professors, responding to DePinho’s version of events.

Boyd is chair of MD Anderson’s Faculty Senate Promotion & Tenure Issues Committee.

photoMoffitt, Ohio State Form Network,
Invite Major Cancer Centers to Join

Moffitt Cancer Center and the Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute earlier this week announced that they are constructing a bioinformatics framework that would enable a multi-center collaboration.

photo
ASCO 2014 Annual Meeting: The Special Awards

 

photoFunding Opportunity
DoD Offering $10.5 Million for Lung Cancer Research

The Department of Defense Lung Cancer Research Program will provide $10.5 million to support innovative, high-impact lung cancer research during fiscal 2014.

photoIn Brief

  • Big Ten Cancer Research Consortium names Susan Goodin exec. officer

  • ASCO launches online resource center for the Affordable Care Act

  • James Graham Brown Cancer Center receives $5.5 million grant

  • MD Anderson signs consulting agreement with Concord Medical Services Holdings for hospital projects in Beijing and Shanghai

  • Mayo Clinic signs agreement with N-of-One for molecular diagnostics

  • CDC is recruiting for director of the Division of Cancer Prevention

photoDrug Approvals

  • FDA approves Vectibix in mCRC with KRAS companion diagnostic

  • European CHMP issues positive opinions for Arzerra in CLL and Halaven in metastatic breast cancer

20140530 - May. 30, 2014
May 2014PDF

Lung Cancer Screening

Model Projects 54,900 New Lung Cancer Cases In Five Years with Nationwide LDCT Screening

A model projecting outcomes for nationwide low-dose CT screening for lung cancer estimated that gradual implementation of the program would detect roughly 54,900 more cases over five years in a high-risk Medicare population. The large majority of new cases would be early-stage disease. 

The model assumes that over a five-year period, an additional 20 percent of high risk patients are offered screening each year. Investigators considered three different screening use scenarios for the implementation: an expected-use scenario based on historic experience with mammography (50 percent of patients offered screening undergo screening every year), a low-use scenario (25 percent), and a high-use scenario (75 percent).

Breast Cancer 
ASCO Publishes Two Clinical Guidelines For Treating HER2-Positive Breast Cancer

The American Society of Clinical Oncology published two clinical practice guidelines on treating women with advanced, HER2-positive breast cancer. 

The first guideline lists appropriate systemic therapies for women newly-diagnosed with advanced disease and those whose early-stage disease progressed to advanced cancer. The second provides recommendations for treating brain metastases. Both guidelines were published in the Journal of Clinical Oncology.

Also:

Prostate Cancer
Study: Delaying ADT Until Symptoms Appear Can Be Safe in Men with a PSA-based Relapse

A study found that it may be safe to postpone androgen deprivation therapy in men with a PSA-only based relapse after prostate surgery or radiation therapy.

Delaying ADT until the onset of symptoms or appearance of cancer on a scan does not substantially compromise long-term survival, according to the population-based observational study. 

“Rising PSA levels trigger a lot of anxiety, and many men want to start treatment as soon as possible,” said lead study author Xabier Garcia-Albeniz, a research associate at Harvard University School of Public Health. 

“These findings suggest that there may be no need to rush to ADT.”

Also:

Non-Small Cell Lung Cancer

Colorectal Cancer
New Biomarker Findings Show Improvement in KRAS Subtype In Phase III Erbitux Trial
Childhood Neuroblastoma
Immunotherapy Shrinks Tumors In Phase I Study at St. Jude
Chemotherapy
Anti-Nausea Drug Successful In Phase III Trial in Highly Emetogenic Chemotherapy
NCI Approved Trials for the Month of May
Drug Development

  • FDA grants orphan drug designation to Advaxis HPV immunotherapy

  • EMA Committee for Medicinal Products for Human Use issues positive opinion for Gardasil

20140529 - May. 29, 2014
ISSUE 20 – MAY 16, 2014PDF


Over $20 Million Carved Out
From Statistical, Operations Centers

The budgets of operations and statistical centers of adult clinical trials groups were cut by about $20.4 million, group chairs say.

The cuts make it difficult for the groups to continue to support ongoing trials and raise questions about the prospects for starting a new generation of trials. 

NCI officials say that, overall, the budget for the groups is staying flat, in part because some of the money is being channeled into 30 sites that received the Lead Academic Participating Site designation. 

LAPS, which are run by cancer centers, will be allowed to charge more for putting patients on studies. 

So where are the cuts? 

photoNo Justification Provided
AAUP Demands Reinstatement of Faculty Denied Tenure Renewal at MD Anderson

The American Association of University Professors sent a letter to Ronald DePinho, president of MD Anderson Cancer Center, urging the reinstatement of two faculty members who were denied tenure renewal without stated reasons.

The letter is a part of AAUP’s response to a request for an investigation, which was triggered by the administration’s refusal to provide justification for denying tenure renewals to faculty who received unanimous votes for renewal from the Faculty Senate Promotions & Tenure Committee. 

photoReport: Rising Treatment Costs Due to 340B Discounts

The 340B drug discount program is causing a rise in the costs of treating cancer patients, according to a new report.

Published by the IMS Institute for Healthcare Informatics, the report, “Innovations in Cancer Care and Implications for Health Systems,” showed that marketplace behaviors, triggered by a lack of eligibility integrity, are a major reason for increasing costs of cancer care, said the Alliance for Integrity and Reform of 340B in a statement.

photoTGen and George Mason Form Precision Medicine Alliance

The Translational Genomics Research Institute and George Mason University announced a strategic research alliance May 6.
Called the TGen-George Mason Molecular Medicine Alliance, the effort is designed to recommend medications and treatments to clinicians based on each patient’s molecular profile.

photoIn Brief

  • Oncology Nursing Society names board of directors

  • American College of Radiology names new officers

  • Bristol-Myers Squibb and Celldex Therapeutics Inc. enter agreement

  • Moffitt Cancer Center collaborates with Vermillion Inc.

  • Children’s Oncology Drug Alliance helps form international collaborative

20140516 - May. 16, 2014
ISSUE 19 – MAY 9, 2014PDF

Oregon Center Launching $1 Billion Program To Identify Lethal Cancers Before They Kill

Brian Druker has some awesome jobs to fill.

As many as 30 scientists and their teams will get to focus on cancer research without having to worry about applying for grants.

“It’s about bringing 20 to 30 people together, giving them sufficient funding—almost like [Howard Hughes Medical Institute] level funding,” Druker said to The Cancer Letter. “If you have 20 to 30 people who are focused on science, working as a team to solve a problem, judged on progress toward the goal, as opposed to how many grants and publications do you have, we think we can make a more rapid contribution in this area.

photoCMS Advisors Express Low Confidence In Low-Dose CT Screening for Lung Cancer

An advisory panel for the Centers for Medicare and Medicaid Services expressed low confidence in low-dose computed tomography as a method for screening for lung cancer in the Medicare population.

Evidence is inadequate to ensure that benefits of the procedure would outweigh harms, the Medicare Evidence Development & Coverage Advisory Committee said at the hearing April 30.

photoBach: LCA Center Certification Untrustworthy; CISNET Models Don’t Match

When it appeared that CT screening for lung cancer was a shoo-in for Medicare coverage, the Lung Cancer Alliance, an advocacy group, started to certify “screening centers of excellence.”

Centers all over the country received this designation from LCA and were listed on the group’s website.

However, as he prepared for a recent Medicare advisory committee meeting, Peter Bach, a pulmonologist and health systems researcher at the Memorial Sloan-Kettering Cancer Center, checked the list of LCA-certified centers.

photoSteven Woolf: Why CMS Should Not Cover LDCT

National coverage for low-dose computed tomography may result in more harm than benefit to the Medicare population at this time, said Steven Woolf, a member of the Medicare Evidence Development & Coverage Advisory Committee.

Speaking at the April 30 MEDCAC hearing, Woolf said coverage would run into many implementation challenges and adherence problems—it would be unlikely that all practices would observe the strict criteria set by the U.S. Preventive Services Task Force and the National Lung Screening Trial, he said.

photoGrowth of the Cost of Drugs Slows to 5.4 Percent per Year; 21 Therapies Launched in 2 Years

The growth of global spending on oncology medicines has slowed over the past five years, according to a report by the IMS Institute for Healthcare Informatics.

Spending on cancer drugs, including those used for supportive care, increased at a compound annual growth rate of 5.4 percent during the past five years, reaching $91 billion in 2013, compared with 14.2 percent from 2003 to 2008. 

photoWomen’s Health Initiative Trial Produced $37.1 Billion in Returns

The overall economic return from the Women’s Health Initiative estrogen plus progestin trial indicates that the changes in practice it produced provided a net economic return of $37.1 billion over 10 years.

photoFDA Oncology Unit Fastest in Approvals Despite Having Highest Workload

A study by a conservative think tank found large differences in performance of the FDA divisions, with oncology demonstrating the agency’s fastest time from application submission to approval.

Paradoxically, the Manhattan Institute found that the oncology division’s staff members had the agency’s highest workload—measured in INDs per staff member at the division.

photoIn Brief

  • David Cole named president of The Medical University of South Carolina

  • Peter Bach’s account of his wife’s death from breast cancer

  • MD Anderson honors 16 junior faculty members

  • US Oncology and Community Oncology Alliance speak to Congress

  • Athena Breast Health Network adopts ASCO’s HL7 Guide for EMRs

  • Eli Lilly & Co. sign agreement with Prasco Laboratories

  • Johns Hopkins receives $10 million from Under Armour 

  • Melanoma Research Alliance and L’Oreal Paris begin campaign

  • Kristin Darby named chief information officer of Cancer Treatment Centers of America

Drug Approvals

  • Zykadia granted accelerated approval for ALK+ NSCLC

  • ADXS-HPV grated orphan drug designation

20140509 - May. 9, 2014
ISSUE 18 – MAY 2, 2014PDF

NCI Officials Open to Fine-tuning Group Budgets
As Advocates Chip Away at NCTN’s Façade

NCI officials said they plan to hold a series of meetings with clinical trials group chairs and group financial officers in order to fine-tune the new National Clinical Trials Network.

“We are in the midst of one-on-one meetings with the group chairs and their financial people and their statistical leadership, [meeting] group-by-group [to] look at the numbers as they exist, and try to understand from both sides what that research budget will support and what it won’t support,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis. 

“Without seeing, from the group perspective, what the resources can and can’t support, it’s hard to know from a system-wide perspective how we will move forward.”

In a telephone conference the institute convened to respond to concern from advocates, Doroshow said, in effect, that the budgets sent to the groups recently didn’t represent fait accompli, and that flexibility was an option.

photoOn Biomedical Malthusianism
Varmus, et al. Propose a Strategy For Saving Biomedical Research

The assumption that growth in research funding would be sustained indefinitely has created an “unsustainable hypercompetitive system” heading toward “long-term decline,” a group of scientists, including NCI Director Harold Varmus, wrote in a paper published in the April 22 edition of the Proceedings of the National Academy of Sciences. 

photoIn Brief

  • CFO Dwain Morris to leave MD Anderson Cancer Center

  • National Academy of Sciences elects new members

  • Dept. of Defense taking applications for $25 million in research grants

20140502 - May. 2, 2014
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