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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
ISSUE 16 – APRIL 18, 2014PDF

 

The Walgreens Connection
ACS Calls on Drug Stores to Stop Tobacco Sales

 

Last week, a blistering opinion piece on The New York Times editorial page focused on the coziness of the relationship between the American Cancer Society and Walgreens.

The piece initially triggered criticism by ACS officials, but then—with no fanfare whatsoever—the society’s CEO called on the drug store chain, as well as others, to stop selling tobacco products.

 

photoConversation with The Cancer Letter
Youle: ACS Stance on Tobacco Sales is Clear

The American Cancer Society prefers to avoid public confrontation with corporate donors, even those who make money by selling tobacco products.

“We have come to the conclusion that in the case of Walgreens, CVS, and other business partners, the best strategy is to work with them rather than against them,” said Robert Youle, vice chair of the board of the American Cancer Society and an attorney with the Denver firm Sherman & Howard.

photoIn a Change of Heart, LCA Endorses NLST

Almost one decade ago, Laurie Fenton-Ambrose, president and CEO of the Lung Cancer Alliance, described the National Lung Screening Trial as “failed” and “outdated.”

photoFunding Opportunity
Defense Department Offering $30.5 Mil In Lung, Ovarian Cancer Research Grants

The Department of Defense announced the availability of several grants through its Ovarian Cancer Research Program and its Lung Cancer Research Program.

20140418_1 - Apr. 18, 2014
ISSUE 15 – APRIL 11, 2014PDF


Varmus Pledges No Funding Gap for NCORP, Blames Snafu on “Unclear Communication”

Following an explosion of criticism, NCI said funding for community oncology clinics would not be interrupted.

In “an open letter to the cancer community” April 10, NCI Director Harold Varmus assured researchers that funding for the NCI Community Clinical Oncology Program sites would continue as it morphs into the NCI Community Oncology Research Program.

photoWhat the Physician Pay Report Won’t Tell You

For a good time, go to the Medicare database and key in the name of your physician friend, foe, or whatever, and presto!—you will see how much that person had billed Medicare in 2012.

This will make for hours of guilty pleasure, especially if you are willing to set aside concerns about—not just privacy—but accuracy.

photoPresident Obama Signs Law Authorizing $126 Million for Pediatric Research over the Next 10 Years

President Obama signed a bill authorizing $126 million for pediatric medical research over the next 10 years, following a rare showing of bipartisanship on Capitol Hill.

photoAACR Presents Awards, Arteaga Becomes President at Annual Meeting

The American Association for Cancer Research presented its 2014 awards at its annual meeting, held April 5-9 in San Diego. The AACR also inaugurated its officers for the next year during its annual business meeting. Carlos Arteaga was named president of the organization. 

photoIn Brief

  • Patricia Goldsmith named CEO of CancerCare

  • Becky DeKay named president of the Association of Community Cancer Centers

  • MD Anderson Cancer Center partners with GlaxoSmithKline

  • AACR taking applications for SU2C-Cancer Research UK Fellowship

20140411 - Apr. 11, 2014
ISSUE 14 – APRIL 4, 2014PDF


Group Chairs: Research in “Crisis”

 

The chairs of the adult clinical trials groups that make up the NCI National Clinical Trials Network said in a letter that recent budget cuts have triggered a “crisis” in clinical research.

Simultaneously, a statement by the president of the American Society of Clinical Oncology, Clifford Hudis, amplified the concerns of the group chairs, and pointed to a separate problem in NCI’s transition to the new structure of clinical research: a three-month gap in funding for community oncology clinics engaged in institute-funded research.

photoAACR, ASCO Publish Reports Criticizing Current State of U.S. Cancer Care

Cancer research remains underfunded, and the U.S. cancer care system as a whole may be unprepared to handle an aging population, according to two separate reports from the American Association for Cancer Research and the American Society of Clinical Oncology.

photoOncologists Tell Congress Community Practices Are Not Adequately Reimbursed

Current Medicare policies do not adequately reimburse cancer care provided in the community setting, the Community Oncology Alliance and the U.S. Oncology Network said in a joint, open letter to members of Congress.

photoAACR Academy Names 2014 Class of Fellows

The American Association for Cancer Research named its 2014 class of elected fellows of the AACR Academy. The fellows will be inducted at the association’s annual meeting in San Diego, April 5-9.

photoIn Brief

  • PCORI Forms Clinical Trials Advisory Panel

  • Samuel Broder named executive VP at Intrexon Corporation

  • Marion Couch named chair of IU Head and Neck Surgery

  • John Powderly II honored by ACCC

  • Two foundations offer $300,000 for neuroendocrine tumor lines

  • Fred Hutch honors thirteen graduate students

  • Community Oncology Alliance publishes IV Fluid Shortage Survey

  • NCCN Updates colorectal assessment guidelines

20140404 - Apr. 4, 2014
March 2014PDF

Metastatic Melanoma

Phase III Trial Retrospective Analysis Finds Talimogene Laherparepvec Reduced Tumors

A retrospective analysis of a phase III study found that talimogene laherparepvec reduced the size of injected tumors and non-injected metastatic melanoma tumors that had metastasized to other parts of the body.

The study evaluated talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor. Full results were presented during an oral session at the Society of Surgical Oncology Annual Cancer Symposium in Phoenix.

Ovarian Cancer 
Avastin-Zybrestat Combination Increases Progression-Free Survival in Phase II Trial

A phase II study evaluating Avastin in combination with Zybrestat demonstrated increased progression-free survival in recurrent ovarian cancer. 

The study, known as Gynecologic Oncology Group protocol 186I, met its primary endpoint of a statistically significant increase in progression-free survival (p < 0.05; HR=0.685) for the combination compared to Avastin alone.

The study is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy.

Non-Small Cell Lung Cancer
IDMC Recommends Halting Phase III Trial Of Onartuzumab in MET-Positive NSCLC

An independent data monitoring committee recommended that the phase III METLung study be stopped due to a lack of clinically meaningful efficacy, following an interim analysis.

Also:

Palliative Care
Study: End-of-Life Chemotherapy Leads to More Deaths in Hospital
Metastases
Y-90 Radioembolization Stabilizes Liver Metastases in 98.5 Percent Of Breast Cancer Patients in Study
Prostate Cancer
Robotic-Assisted Surgery Offers Better Cancer Control, Study Says
NCI Approved Trials for the Month of March
Drug Approvals

  • European Commission approves subcutaneous MabThera

  • Japan approves Lonsurf combination tablet

  • UK’s National Institute for Health and Care Excellence recommends Pixuvri

  • FDA Microbiology Devices Panel recommends cobas HPV test for approval

  • FDA revises prescribing information for Thyrogen

  • And more…

20140331 - Mar. 31, 2014
ISSUE 13 – MARCH 28, 2014PDF


FDA Advisory Panel Unanimously Favors New Stool DNA Colorectal Screening Test

 

The FDA Molecular and Clinical Genetics Panel voted 10-0 to recommend approval of Cologuard—a noninvasive, multitarget stool DNA screening test for colorectal cancer.

Sponsored by Exact Sciences Corp., Cologuard outperformed a standard fecal immunochemical test in a study published March 19 in the New England Journal of Medicine.

photoRising Costs at NCI Threaten to Overtake
Slim Increases In Budget Appropriations

Sometimes a funding increase can be no increase at all.

NCI’s budget was increased by 2.8 percent for the current 2014 fiscal year, or about $134 million, restoring about 53 percent of previous cuts made by sequestration. The institute’s total budget stands at $4.9 billion.

photoIn Brief

  • Caplan Receives NSB Public Service Award

  • Fazio and Kantarjian Receive Lifetime Achievement Awards

  • Pienta named director of Johns Hopkins Prostate Cancer Program

  • American Society of Hematology awards 15 bridge grants

  • Stewart named incoming president of Patient Advocate Foundation

  • Ohio State signs agreement with MedVax Technologies Inc.

  • UC San Francisco signs agreement with Advaxis Inc.

  • Georgia Regents receives CEO Gold Standard accreditation

  • The winners of the Research!America Advocacy Awards

  • European Commission approves MabThera SC

  • Japan approves LonSurf combination tablet

20140328 - Mar. 28, 2014
ISSUE 12 – MARCH 21, 2014PDF


Does a B from USPSTF Guarantee Coverage? Lung Screening will Define Medicare Stance

 

The Centers for Medicare and Medicaid Services is facing the formidable challenge of deciding what kinds of patients should be screened for lung cancer. 

The agency’s Medicare Evidence Development & Coverage Advisory Committee will meet April 30 to decide how the positive findings of a large randomized trial and the recommendation the U.S. Preventive Services Task Force should be translated into policy.

The controversy over screening for lung cancer will demonstrate how scientific findings influence the standard of care in the new healthcare system. Under the Affordable Care Act, USPSTF grades translate into coverage mandates for private insurers.

photoConversation with The Cancer Letter
Kazerooni: The Case for Broad Coverage

The Cancer Letter asked Ella Kazerooni, a professor of radiology at the University of Michigan, chair of the American College of Radiology Committee on Lung Screening, and vice chair of the lung screening panel of the National Comprehensive Cancer Network, to lay out the rationale for a proposal for broad coverage for lung screening.

photoIn Brief

  • Alan Ashford named center director at UCSF

  • Edith Perez receives Claude Jacquillat Award

  • NCI announces 2013 Cancer Center Clinical Investigator Team Leadership Awards

  • Chad Ellis named associate director at UNC Lineberger

  • Tripathy joins MD Anderson as breast medical oncology chair

  • Thayer named chief of surgical oncology at University of Nebraska

  • Bayer Pharma and Ventana enter agreement

  • MD Anderson signs three-year agreement with MedImmune

20140321 - Mar. 21, 2014
ISSUE 11 – MARCH 14, 2014PDF


NCI Rethinks Cancer Center Grants

 

NCI is moving toward adopting a formula that will fundamentally restructure the manner in which cancer centers are funded.

The new approach, developed by a working group of the National Cancer Advisory Board, seeks to eliminate the advantage that comes with a center’s longevity in the program.

As it stands, just being in the centers program for many cycles can build up an institution’s funding base. This favors older centers. 

photoRobert Cook-Deegan’s Viewers’ Guide To the Super Bowl of Gene Patent Cases

Patent litigation is a blood sport if you see corporations as people and count spilled ink or loss of money as hemorrhage. 

One of the most closely watched cases in recent years centers on genetic testing for BRCA1 and BRCA2 genes. 

On March 10, Judge Robert Shelby from the Federal District Court for Utah denied Myriad Genetics’ motion for a preliminary injunction against its competitors that had entered the market starting June 13, 2013, when the Supreme Court handed down its ruling in Association of Molecular Pathology v. Myriad Genetics.

20140314 - Mar. 14, 2014
ISSUE 10 – MARCH 7, 2014PDF


NIH to Review Intramural Program

NCI’s Intramural Spending is 17 Percent, Higher than 11.1 Percent NIH-Wide Level


NIH has launched a systematic examination of its intramural program, which accounts for 11.1 percent of its $30 billion budget.

The program was last examined in 1993, pursuant to a mandate from the House Appropriations Committee.

That examination was written by a panel co-chaired by Paul Marks, then president of Memorial Sloan-Kettering Cancer Center and Gail Cassell, then chair of the University of Alabama Department Microbiology.

photoPresident Requests Extra $200 Mil for NIH

President Barack Obama’s $3.9-trillion budget proposal for the 2015 fiscal year would bump NIH funding up to $30.2 billion—a $200 million increase over fiscal 2014—and would include an additional $8 million for NCI, totaling $4.931 billion for the institute.

photoHPV Vaccines Should be Priority, says President’s Cancer Panel

Human papillomavirus vaccines are underused in the U.S. and need to be made a national public health priority, according to a report from the President’s Cancer Panel.
In a presentation to the National Cancer Advisory Board Feb. 27, panel chair Barbara Rimer outlined three goals to accelerate uptake of HPV vaccines, including having providers strongly encourage HPV vaccination to adolescents when other vaccines are being administered.

photoNCI Publishes Report on Pancreatic Cancer

NCI has issued a report detailing a “scientific framework” for advancing research on pancreatic ductal adenocarcinoma, indicating potential new funding opportunities for genomic studies for early detection of pancreatic cancer.

The institute’s report is the result of the Recalcitrant Cancer Research Act, a bill proposed by the Pancreatic Cancer Action Network, and passed Jan. 2, 2013.

photoIn Brief

  • Pasche named center director at Wake Forest Baptist Medical Center
  • Jiali Han named Rachel Cecile Efroymson Professor in Cancer Research at the Indiana University Simon Cancer Center
  • Carol Bier-Laning will lead CTCA Head and Neck Cancer Program
  • Curie-Cancer renews partnership with DNA Therapeutics
  • A correction
20140307 - Mar. 7, 2014
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