20151204 - Dec 4, 2015
ISSUE 44 – DEC. 4, 2015PDF



Mary Pazdur, 63, Dies of Cancer;

What Her Husband Has Learned

The job interview wouldn’t last more than 15 minutes, Richard Pazdur believed.

So, on a June morning in 1999, his wife Mary settled down to wait at a restaurant near the FDA buildings alongside Rockville Pike.

The restaurant turned out to be Hooters, and Mary ended up spending three hours at the joint known for all-you-can-eat chicken wings served by scantily clad waitresses known as Hooters Girls.

“How much Hooters coffee can you drink?” Mary said frequently, retelling the story of her introduction to FDA, Washington and cancer politics.

Rick’s Search for Meaning

On Nov. 17, Richard Pazdur, director at the FDA Office of Hematology and Oncology Products, spoke about the role that has been thrust upon him: that of a “regulator/advocate.”

“What we’re seeing now is not a patient voice but a patient cry—wanting to have their position heard,” said Pazdur, speaking at a Washington conference sponsored by Friends of Cancer Research.

NCI Director’s Report

Lowy: Higher RPG Success Rates in 2015;

Continuing Resolutions Will Slow Progress

NCI awarded about 635 R01s in 2015, up from 629 in 2014, said NCI Acting Director Doug Lowy at a recent joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors.

The number of R01 awards fell short of pre-sequestration levels, but there has been a substantial increase in R21 applications—from 225 in 2012 to about 355 in 2015.

Funding Opportunity

Debbie’s Dream Foundation Offering $200,000 in Grants

Debbie’s Dream Foundation: Curing Stomach Cancer launched two research grants totaling $200,000 for the 2015-2016 grant cycle. A Career Development Award for $150,000 and a Young Fellowship Grant for $50,000 are being offered.

In Brief

  • Jennifer Nam Choi named chief of oncodermatology at Northwestern Memorial
  • Robert Hauser named vice president of clinical analytics at Cancer Treatment Centers of America
  • Mia Levy to be director of health information and strategy at Vanderbilt-Ingram Cancer Center
  • City of Hope announces three personnel changes
  • David Flockhart, board member of the Personalized Medicine Coalition, died Nov. 26
  • Fox Chase-Temple Health form collaboration with Accutest Research Labs in India
  • Manipal Hospitals to use IBM Watson technology
  • ASTRO publishes template for long-term survivor plans
  • West Cancer Center opens its East Campus
  • National Health Care Anti-Fraud Association names it’s 2015 Investigation of the Year
Drugs and Targets

  • FDA approves Opdivo in renal cell carcinoma
  • European Commission grants marketing authorization for Kyprolis in multiple myeloma
  • EMA accepts anamorelin application for review
  • MD Anderson and Boehringer Ingleheim announce collaboration
  • Morphotek and Targeted Alpha Therapy Group to collaborate in ovarian cancer
  • Roche and Upsher-Smith Laboratories to develop VAP-1 inhibitor
  • Caris Life Sciences and Syapse to collaborate on genomic information
20151120 - Nov 20, 2015
ISSUE 43 – NOV. 20, 2015PDF



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

Also:

CBER’s All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Therapy

One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

Capitol HillFDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

NCI Announces Winners of Outstanding Investigator Awards

NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.

Developed last year, the grant program provides funding to investigators with outstanding records of productivity in cancer research to support projects of unusual potential in cancer research.

The award provides funding of up to $600,000 in direct costs each year for seven years. One goal of the award is to provide investigators with substantial time to break new ground or extend previous discoveries to advance biomedical, behavioral or clinical cancer research.

In Brief

  • Kantoff named chair of MSKCC Department of Medicine
  • Michael Lang named CPRIT chief product development officer
  • Alexandra Levine receives award from Los Angeles County Medical Association
  • Steven Rosen receives Lifetime Achievement Award from the Israel Cancer Research Fund
  • International Cancer Genome Consortium publishes 1,200 whole cancer genome sequences online
  • ASCO publishes 11 principles for CMS payment systems
  • MD Anderson and Codiack BioSciences form research agreement
  • Pan-Mass Challenge donates $45 million to Dana-Farber
  • AARP publishes report on drug retail prices and median household income
Drugs and Targets

  • Darzalex granted accelerated approval in multiple myeloma
  • Ninlaro first protesome inhibitor approved in multiple myeloma
  • Eli Lilly and Merck extend phase III Alimta-Keytruda study collaboration

 

The Cancer Letter will take a publication break

for Thanksgiving, and return Dec. 4.

20151119 - Nov 19, 2015
SPECIAL REPORT – NOV. 18, 2015 



Congressional Panel Chair Questions Whether J&J, Brigham Reported Morcellation Adverse Events to FDA

The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.

At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.

At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.

FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years

FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.

“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”

photoJ&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters

Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.

“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”

Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.