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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