20140711 - Jul 11, 2014
ISSUE 28 – JULY 11, 2014PDF



NCI to Implement More Transparent Formula
For Calculating Cancer Center Support Grants

NCI took another step toward adopting a new formula for determining the size of cancer center support grants, with the National Cancer Advisory Board accepting a report from a working group that has been working on the problem since the fall of 2012. 

The schema proposed by the working group was accepted by the advisory board at its meeting June 23. It recommends broad organizing principles rather than specific numbers. 

After the Plenary
Don Berry: In NeoALTTO & ALTTO Trials, Neoadjuvant Response Predicts Adjuvant

An article in the June 6 issue of The Cancer Letter described plenary presentations at ASCO 2014. One presentation was the adjuvant breast cancer clinical trial ALTTO in HER2-positive disease, which “was chosen [for the plenary session] because it addressed the reliability of pathological complete response as a surrogate for patient benefit.”  

photoCounterpoint
George Sledge Responds To Berry’s Letter: Neoadjuvant Doesn’t Predict Adjuvant In Breast Cancer

As always, I both enjoyed and learned something interesting from Dr. Don Berry, one of the great biostatisticians of our era. I find, reading his analysis of ALTTO and NeoALTTO, much that I agree with. I am certainly no statistician, and must bow to his statistical analysis of ALTTO and NeoALTTO. And yet at the same time I think it misses the point. So I will beg to differ.

Also: Don Berry’s Rejoinder

photoAACR Changes Its Logo— For the Fifth Time Since 2000

The American Association for Cancer Research ushered in the year 2000 with a round logo that combined the lamp of knowledge with a map of the Americas and an aspirational slogan in Latin.

The 26-year-old logo gave way to one that looked more corporate. However, AACR didn’t stop at just one redesign. It changed the logo four more times. 

photoNIH Funding Opportunity
Outstanding Investigator Award In Cancer Research Available

The NIH has published a funding opportunity announcement for the Outstanding Investigator Award in any area of cancer research.

photoIn Brief

  • Three appointed to leadership positions at St. Jude

  • Duke’s Amy Abernethy named chief medical officer at Flatiron Health

  • William Hogan joins University of Florida as director of bioinformatics

  • J. Alan Diehl named associate director of basic sciences at MUSC

  • Vincent O’Neill named chief medical officer of Exosome Diagnostics

  • Joseph Haywood named president of FASEB

  • Thomas Jefferson University receives $110 million gift

  • Stand Up to Cancer Canada launched

  • Bristol-Myers Squibb announces collaboration with Duke University

  • Pew Charitable Trusts announce class of cancer research scholars

  • Steven Bangert named CEO of the Year by the American Cancer Society

photoDrug Development

  • Breakthrough Therapy designation granted to CTL019 in ALL

  • European Commission approves Halaven for metastatic breast cancer

  • Breakthrough Therapy designation granted to blinatumomab in Ph- ALL

  • Mylan launches generic Carboplatin Injection in multi-dose vials

20140704 - Jul 3, 2014
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

20140627 - Jun 27, 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

20140620 - Jun 20, 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

20140613 - Jun 13, 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

20140530 - May 30, 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

20140516 - May 16, 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

20140509 - May 9, 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

20140502 - May 2, 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

20140425 - Apr 25, 2014
ISSUE 17 – APRIL 25, 2014PDF


No Justification Provided
DePinho’s Nixing of Tenure Renewals
May Bring Censure to MD Anderson

A year before Kapil Mehta’s tenure term expired last August, the 11-member Promotions and Tenure Committee at MD Anderson Cancer Center had unanimously recommended renewal.

“I’ve done everything I’m supposed to do during my tenure,” Mehta said to The Cancer Letter. “I’ve done publications, organized international meetings, service, teaching—everything.” 

Mehta’s application was personally rejected by MD Anderson President Ronald DePinho, who overruled the PTC recommendation in May 2012.

Mehta appealed, and a second committee—the Faculty Appeals Panel—endorsed the PTC’s recommendation to renew Mehta’s tenure. However, the administration wasn’t swayed. DePinho’s decision stood.

photoItri Pays Fine, Agrees Not to Serve As Company Officer for Five Years

The Securities and Exchange Commission earlier this week said it has settled insider-trading charges against a prominent cancer researcher who was also an executive of a now-defunct company. 

photoASCO Releases Three Guidelines For Survivorship Care

The American Society of Clinical Oncology published three clinical practice guidelines for the prevention and management of neuropathy, fatigue, depression, and anxiety. 

photoIn Brief

  • Gareth Morgan named director of UAMS myeloma institute

  • Michael Gordon named medical director of Virginia G. Piper Cancer Center Clinical Trials

  • Clinical Research Forum names its Top Ten achievement awards

  • Conquer Cancer Foundation names 2014 Merit Award winners

photoFDA Approvals

  • Cobas HPV Test approved for primary cervical cancer screening

  • Arzerra sBLA approved for previously untreated CLL

  • Cyramza approved for advanced stomach cancer