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ISSUE 7 – FEB. 14, 2014PDF

A meeting of the FDA Oncologic Drugs Advisory Committee has become a rare occurrence.

Why?

Because cancer drugs are getting better, as are applications for their approval, said Richard Pazdur, director of the FDA Office of Hematology and Oncology Products. 

“Drug development is much more focused, and decisions are being made on the basis of understanding the molecular basis of the disease rather than the number of responses observed in an early phase study,” Pazdur said.

photoGuest Editorial 
Once Again, Hype Overshadows Data
In Breast Cancer Screening Debate

By Otis W. Brawley

Studies assessing the merits of cancer screening tend to get a lot of play in the news media. It seems every six months or so a new study makes a big splash.

photoDrasga and Einhorn Respond to Single Payer Proposal Rebuttal

In a recent article published in the Journal of Oncology Practice, oncologists Ray Drasga and Lawrence Einhorn called on their colleagues to support “an improved Medicare for all” program.

The provisions of the Affordable Care Act are insufficient to solve the crises facing American cancer patients, they wrote in the journal published by the American Society for Clinical Oncology.

photoIn Brief

  • Waun Ki Hong will retire as head of MD Anderson Cancer Center’s Division of Cancer Medicine

  • Fraser Symmans named director of CALGB Alliance Translational Research Program

  • American Cancer Society adds five officers to redesigned volunteer board of directors, with Pamela Meyerhoffer as chair

  • John Walter, president and CEO of The Leukemia & Lymphoma Society, steps down

  • MD Anderson’s Jim Allison awarded Szent-Györgyi Prize

  • AVEO Oncology and Astellas Pharma Inc. to End Tivozanib Agreement 

20140214 - Feb. 14, 2014
ISSUE 6 – FEB. 7, 2014PDF

“Confidential and Proprietary” Document Proposes Plan for National Network

You might think of this as an event isolated to Columbus or central Ohio: 

On Feb. 7, OhioHealth, a health system that operates not-for-profit, faith-based hospitals in central Ohio and competes with Ohio State University, said it would join the outreach network of MD Anderson Cancer Center, located almost 1,200 miles away.

photoConversation with The Cancer Letter 
McKinsey Charge: Create Plan 
To Expand MD Anderson’s Reach

Responding to questions from The Cancer Letter, Jim Newman, director of external communications at MD Anderson, confirmed that the presentation obtained by The Cancer Letter was prepared under a contract by McKinsey & Company.

photoCVS to Stop Tobacco Sales at Pharmacies

CVS Caremark plans to stop selling cigarettes and other tobacco products at more than 7,600 CVS/pharmacy stores by Oct. 1.

The country’s largest drug store chain in overall sales estimated that it will forego approximately $2 billion—about 17 cents per share—in revenues on an annual basis from snuffing out Big T.

photoDrug Development
Tivozanib Trial Discontinued Due to Insufficient Enrollment

AVEO Oncology and Astellas Pharma Inc. discontinued a phase II study of tivozanib in locally recurrent or metastatic triple-negative breast cancer due to insufficient enrollment.

photoIn Brief

  • Wendy Selig elected president Of NCCR board of directors

  • Dana-Farber Receives $900,000 for ovarian cancer research

  • Richard Folkers named director of communications for the Foundation for the NIH

  • Sarah Cannon to integrate cancer programs with HealthONE hospitals

  • Amgen and Merck to collaborate on oncolytic immunotherapy

  • Univ. of Pittsburgh selects GenomAnalytics platform for TGCA data

  • Health Canada approves Aptima HPV assay

  • Definiens and Clarient sign agreement over image analysis software

20140207 - Feb. 7, 2014
JANUARY 2014PDF

Pancreatic Cancer

Abraxane-Gemcitabine Combination Extends Overall Survival in Phase III Trial

A phase III trial of Abraxane extended overall survival in metastatic pancreatic cancer, with some patients surviving longer than three years, when used in combination with gemcitabine. 

The updated OS data from the Metastatic Pancreatic Adenocarcinoma Clinical Trial was presented at the American Society of Clinical Oncology Gastrointestinal Conference in San Francisco. 

Leukemia
Phase III Trial of Imbruvica Halted, Following
Increases in Progression-Free Survival

A phase III study of Imbruvica in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma was stopped early following an interim analysis and at the recommendation of an independent data monitoring committee, which concluded the study demonstrated a significant difference in progression-free survival compared to ofatumumab.

Breast Cancer
Long-term Follow-up Shows ADH and ALH Tissue
Abnormalities Can Carry Similar Risk

Contrary to existing understanding, long-term follow-up of patients with two types of breast tissue abnormalities suggests that both types of abnormalities have the same potential to progress to breast cancer.

Kidney Cancer
Patients on Hypertension Meds Lived Longer, Analysis Shows
Liver Cancer
Post-Hoc Analysis of ThermoDox Suggests OS Improvement
Prostate Cancer
Study: Gene Assay Can Provide Valid Prognostic Information
Colon Cancer
Studies of Oncotype DX Test Presented at ASCO Symposium
Lung Cancer
MicroRNA Assay Detects Cancer Two Years Before LDCT in Study
NCI Approved Trials for the Month of January
FDA News

  • Accelerated Approval granted to Mekinist-Tafinlar combination in unresectable or metastatic melanoma

  • 510(k) Clearance granted to spectral breast density measurement application

  • Reagent system approved for prevention of graft-versus-host disease

  • FDA launches advisory committee membership nomination web portal
  • Orphan drug designation granted to BL-8040 as a treatment for stem cell mobilization
  • FDA lifts clinical hold on tosedostat
  • And more…
20140203 - Feb. 3, 2014
ISSUE 5 – JAN. 31, 2014PDF

Congress Mandates NIH Cut PR Costs, Coordinate Spending on Communications

Congressional appropriators instructed NIH to cut spending on communications activities and coordinate the broad range of activities that fall under the category of public relations.

The mandate is a part of the report that accompanied the recently passed appropriations bill.

photoIPRI’s Peter Boyle on Closing the Gap In Global Cancer Treatment and Outcomes

The International Prevention Research Institute has published “The State of Oncology 2013,” a report that highlights disparate cancer outcomes between higher- and lower-resource countries and proposes long-term recommendations. 

photoPresident Calls For Reversing Cuts to Basic Research Budget

In his state of the union address to Congress Jan. 28, President Barack Obama called for reversing the cuts made to basic research in the federal budget.

photoDrasga, Einhorn Make Appeal For Single-Payer Healthcare

In a feature article published in the Journal of Oncology Practice, oncologists Ray Drasga and Lawrence Einhorn called for their colleagues to endorse single-payer healthcare.

The journal is published by the American Society for Clinical Oncology.

photoACS, SU2C Commit $20 Million For Lung Cancer Dream Team

The American Cancer Society and Stand Up To Cancer announced a collaboration to fund translational research and advocacy programs.

photoIn Brief

  • Indiana University cancer center receives $15 million pledge from Vera Bradley Foundation

  • Hope Funds for Cancer Research announce James D. Watson Award 

  • Dept. of Defense offers $580 million in medical research funding

  • Justin Klamerus named chief quality officer at Karmanos Cancer Institute

  • Angela Davies named chief medical officer of Champions Oncology

  • UCSF and Quest Diagnostics form collaboration

  • John Porter to receive Public Welfare Medal from the National Academy of Sciences

photoFDA News

  • FDA lifts clinical hold on tosedostat

  • U.K. National Institute for Health and Care Excellence issues final opinion on Pixuvri

20140131 - Jan. 31, 2014
ISSUE 4 – JAN. 24, 2014PDF

Conversation with The Cancer Letter:
Seffrin To Retire After Restructuring ACS

The American Cancer Society has started a search to replace its chief executive officer, John Seffrin.

Seffrin, who became the CEO in 1992, recently completed streamlining of the society’s organizational structure, eliminating the autonomy of divisions, decreasing the number of board members, and making the century-old organization into a single corporate entity.

photoASCO, COA Present Plans For Cancer Care
Beyond the Fee-for-Service Pay Structure

The Community Oncology Alliance and the American Society of Clinical Oncology issued a joint statement on payment reform in cancer care and proposed alternative approaches to paying for cancer care. 

photoKomen Officials Say Charity is Stabilizing Despite 22 Percent Drop in Contributions

The Susan G. Komen Breast Cancer Foundation reported a 22 percent decline in contributions in fiscal 2013—totalling over $77 million—in recent financial statements.

Overall, the charity’s revenues fell by 18 percent from the 2012 fiscal year.

photoFDA News

  • Reagent system approved for the prevention of Graft-Versus-Host Disease

  • FDA launches advisory committee membership nomination web portal 

  • Orphan designation granted to BL-8040 for stem cell mobilization

  • EU CHMP issues positive opinion for Roche’s subcutaneous MabThera

20140124 - Jan. 24, 2014
ISSUE 3 – JAN. 17, 2014PDF

Officials: “Separations” in Normal Range
As Critics Claim Brain Drain in the Clinic

When surveyed by the Faculty Senate in October 2012, nearly a third of faculty members at MD Anderson Cancer Center who responded said they were likely to leave the institution within three years.

Of that number, 9.3 percent said they were likely to leave within one year.

photoAs Leadership Changes Continue, Fontaine, Leach Get New Posts
In another round of changes in the executive suite at MD Anderson Cancer Center, Dan Fontaine was appointed head the institutional advancement division, President Ronald DePinho announced in an email to the faculty and staff. 
photoNIH, NCI Get Higher Funding in 2014 Budget
Congress has passed a $1.012 trillion omnibus spending bill, easing the sequestration cuts set for fiscal 2014 and keeping the government open through September. President Barack Obama is expected to sign the bill by Saturday.
photoCDC: Lung Cancer Rates Drop Following Anti-Smoking Efforts
The rate of new lung cancer cases decreased among men and women from 2005 to 2009, largely due to tobacco control efforts, according to a report from the Centers for Disease Control and Prevention.
photoHoward Hughes Medical Institute Seeks up to 25 New Researchers
The Howard Hughes Medical Institute is seeking to appoint up to 25 new biomedical researchers through a national open competition. The initiative represents an investment of approximately $150 million in basic biomedical research over the next five years.
photoIn Brief

  • Baylor campus plans to build joint cancer center 
  • Beck named deputy director at Fox Chase Cancer Center 
  • Burtness named co-director of Yale Cancer Center Developmental Therapeutics Research Program
  • Dmitri Alden elected to French National Academy of Surgery
  • MD Anderson and Pfizer to launch immunotherapy collaboration
  • Regeneron Pharmaceuticals and Geisenger Health System to collaborate on genomics
20140117 - Jan. 17, 2014
ISSUE 2 – JAN. 10, 2014PDF

Orlando Hospital Severs MD Anderson Ties,
Forming Center with University of Florida

On Jan. 30, somebody will have to climb to the top of Orlando Health’s 10-story Charles Lewis Pavilion to cover up—or start removing—the backlit letters that, with a halo effect created by LED lights, broadcast the health system’s affiliation with MD Anderson Cancer Center.

The name of the distant, venerable cancer center will vanish from Orlando’s skyline. The distinctive red swoosh that symbolically negates the word “cancer” will be gone also.

photoOrlando Health President Mark Roh:
We Opted For a Florida-Centric Strategy

Orlando Health is choosing a partnership over an affiliation, said Mark Roh, president of the Florida cancer center that’s ending its relationship with MD Anderson Cancer Center. Instead, Roh’s hospital is joining the University of Florida to create the UF Health Cancer Center at Orlando Health.

photoLudwig Cancer Research Donates
$540 Million to Six Centers

Ludwig Cancer Research donated a total of $540 million to six of its centers, located at institutions across the country.

photoAVEO’s Tivozanib Fails In Colorectal Cancer

AVEO Oncology said that data from a planned interim analysis of the phase II BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. 

photoTask Force Issues Guideline On LDCT Lung Screening

The U.S. Preventive Services Task Force released its final recommendation statement on screening for lung cancer with low-dose computed tomography.

photoACS: Decline in Death Rates Saved
Over 1.3 Million Lives

Declines in death rates over past two decades have added up to a 20 percent drop in the overall risk of dying from cancer, according to the American Cancer Society’s annual statistics report.

photoIn Brief

  • Gary Lyman to co-direct Fred Hutch outcomes research

  • Gary Schwartz named chief of NewYork-Presbyterian/Columbia University Medical Center Division of Hematology/Oncology 

  • Richard Gannotta named president of Northwestern Memorial Hospital

  • NCI Director Harold Varmus wins Medal of Honour from International Agency for Research on Cancer


FDA News

  • Accelerated Approval granted for Mekinist-Taflinar combination

  • European Commission amends Erbitux label

  • FDA and EMA launch joint initiative for generics inspections

20140110 - Jan. 10, 2014
ISSUE 1 – JAN. 3, 2014PDF

Who Makes This Drug?
Secretive Contract Manufacturing Arrangements Complicate Solutions to Shortages of Generics

By Rena M. Conti
The closing of Ben Venue Laboratories, a company that produces a large share of generic drugs used by America’s oncologists, brings into focus a little-understood business practice that exacerbates the problem of drug shortages and shows why the industry and federal regulators have been unable to resolve them.

photoReport to the Nation: Death Rates Continue To Decline Across All Major Disease Sites

Death rates continued to decline for all cancers combined for men and women of all major racial and ethnic groups and for most major cancer sites, according to the Annual Report to the Nation on the Status of Cancer. Rates for both sexes combined decreased by 1.5 percent per year from 2001 through 2010.

photoAn Appreciation: Janet Rowley, “Translational Research Pioneer”

Janet Rowley, a pioneer in connecting the development of cancer with genetic abnormalities, died from complications of ovarian cancer on Dec. 17 at her home. She was 88.

photoIn Brief

  • Julie Vose Elected President of ASCO
  • 2014 Breakthrough Prize Winners Announced
  • Andrea Sloan, Prominent Ovarian Cancer Patient Dies
20140103 - Jan. 2, 2014
ISSUE 46 – DEC. 13, 2013PDF

CPRIT Official Indicted for Skipping Peer Review

By Paul Goldberg
A grand jury in Travis County, Texas, indicted a former official of the Cancer Prevention and Research Institute of Texas for bypassing peer review in awarding an $11 million grant to a Dallas-based company.

photoWhy I Don’t Want to Pay for Your Horoscope:
Reflections on FDA Warning to 23andMe

Guest Editorial by Jim Evans
There’s been much recent gnashing of teeth (at least within the narrow and rather insular world of do-it-yourself genomics) about the gall of the FDA in choosing to issue a warning letter to 23andMe, effectively shutting down marketing of their direct-to-consumer personal genomic profiling. And adding to 23andMe’s woes, a class action suit has been filed against them.

photoBipartisan Deal Eases Some Budget Cuts By Extending Sequestration Through 2023

By Matthew Bin Han Ong
The House of Representatives voted 332-94 to approve a two-year budget outline Dec. 12 that would cancel $63 billion in sequester cuts for 2014 and 2015—in exchange for extending sequestration through 2023.

photoIn Brief

  • Thomas Burke stepped down as executive vice president and physician-in-chief at MD Anderson Cancer Center
  • Edward Jackson named chair of the Department of Medical Physics at the University of Wisconsin School of Medicine and Public Health
  • David Chang appointed professor of plastic surgery at the University of Chicago School of Medicine
  • Steve Mackin named chief operating officer of Cancer Treatment Centers of America
20131217_4 - Dec. 17, 2013
ISSUE 45 – DEC. 6, 2013PDF

example

Wall Street Analyst Who Sounded Alarm
Over Prostate Cancer Drug Provenge In JNCI
Settles with SEC Over Shorting Dendreon Stock

The lead author of a paper that argued that the prostate cancer immunotherapy Provenge endangered lives of cancer patients has entered a settlement agreement with the Securities and Exchange Commission.

The agreement states that Marie Huber, an analyst at a hedge fund, had prepared and anonymously circulated a paper about Provenge (sipuleucel-T) at a time when her put options in Dendreon Inc., the drug’s sponsor, were about to expire.

photoNCI Urged to Boost Gastric Cancer Funding

A group of members of both chambers of Congress is urging NCI to increase funding for research in gastric cancers—the latest in a string of advocacy initiatives to carve out fiscal support for specific diseases.

photoIn Brief

  • Lenora Johnson to leave NCI Office of Communications

  • Adrienne Lang steps down as VP for executive operations at MD Anderson Cancer Center

  • Michael Foley selected to lead the Tri-Institutional Therapeutics Discovery Institute Inc.

  • Beti Thompson to present AACR Distinguished Lecture on Cancer Health Disparities

FDA News

  • Supplemental new drug application for Nexavar tablets (sorafenib) approved

  • 510(k) clearance granted to an estrogen receptor image analysis and digital read application for breast cancer

  • Aptima HPV 16 18/45 genotype assay approved

  • Priority Review granted to ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy

  • FDA and the European Medicines Agency grant orphan drug designation to IMAB362

20131217 - Dec. 17, 2013