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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
April 2014PDF

 

Drug Approvals

FDA Approves Cyramza for Stomach Cancer;
Zykadia in NSCLC; Lipiodol for HCC Imaging;
And Cobas HPV Test for Primary Screening

FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. 

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for unresectable or metastatic cancers that have been treated with a fluoropyrimidine- or platinum-containing therapy. 

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. 

Prostate Cancer 
Phase III Custirsen/Docetaxel/Prednisone Trial Fails Primary Endpoint of Overall Survival

Top-line results from a phase III trial evaluating the addition of custirsen to standard first-line docetaxel/prednisone therapy did not meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer when compared to docetaxel/prednisone alone.

Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance.

Thyroid Cancer
Oral Sorafenib Trial Published in The Lancet; Tablets Extend PFS in Metastatic Disease

Last year, a phase III trial demonstrated Nexavar (sorafenib) tablets significantly extended progression-free survival in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Results from the trial, named DECISION, were recently published in The Lancet. Based on these data, Nexavar was approved by FDA in November 2013.

Melanoma
Phase III Trial Fails to Extend OS After Meeting Primary Endpoint Of Durable Response Rate
Breast Cancer

 

Non-Small Cell Lung Cancer
LDK378 Demonstrates 58 Percent Overall Response Rate in Phase I
Survivorship
ASCO Releases Three Guidelines For Cancer Survivorship Care
NCI Approved Trials for the Month of April
More Drug Approvals

  • FDA approves sBLA for Arzerra in CLL
  • FDA and European Commission grant orphan status to volasertib in AML
  • CHMP issues positive opinion for Mekinist in metastatic melanoma
  • sNDA submitted for Imbruvica in CLL and SML based on phase III data
20140501 - May. 1, 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

20140425 - Apr. 25, 2014