Iconocast Logo

Welcome To Iconocast

How to add a URL link from your web site to the Iconocast web sites

Virtual tour of Southern California
blank

 

Recent News and Articles on the Keywords: breast cancer + fda approved + fda  Related to the article below (Last Update: 5/12/2008)

OncoVista seeks FDA approval to market breast-cancer detection device
Bizjournals.com, NC - May 6, 2008
The company develops and markets kits in the European market for detecting metastatic breast and colon cancer. AdnaGen's breast cancer device has the ...
GTx, Inc. Reports First Quarter 2008 Financial Results
WELT ONLINE, Germany -
In 2006, GTx and Ipsen Group entered into a development and collaboration agreement for toremifene citrate in all indications except breast cancer for ...GTXI
Extended Accrual Time and Decreased Sample Size for OVATURE, a ...
CNNMoney.com - May 9, 2008
Under US law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the ...
A Good Framework for Distributing Information on Off-Label Uses
American Enterprise Institute, DC - May 8, 2008
... describes how information about a new use of the breast cancer drug Herceptin was slow in reaching oncologists. The Food and Drug Administration (FDA) ...
BCA E-Alert May 2008
Bay Area Indymedia, CA - May 8, 2008
Some BHT contain the hormone estriol, which has never been approved by the FDA for any drug. so we don't know how they compare to HT. ...
Eli Lilly's Ladies Drug Campaign: Kind of Strange
CNBC, NJ -
(%) ] debuted the campaign yesterday for the osteoporosis drug which the Food and Drug Administration approved last September as a breast cancer ...
Southwest Foundation for Biomedical
Ad-Hoc-News (Pressemitteilung), Germany -
The leading drug candidate, a reformulated oral contraceptive, involves seeking an accelerated approval from the FDA. Four additional drug development ...
New Treatment For Early Stage Breast Cancer Approved By FDA
Boston Channel.com,  USA - Apr 17, 2008
BOSTON -- There's a new treatment for early stage breast cancer. As Mary Saladna reported Thursday, doctors say the therapy is safer than traditional ...
Delaying a PC revolution in cell diagnosis
ZDNet - May 8, 2008
Then what if every application, and every input, had to be separately inspected and approved by the FDA? Iknoisys of New Haven says it has just such a ...

RTT News
ImClone, FDA Agree On Design For Breast Cancer Study - Update
RTT News, NY - Apr 22, 2008
About two-thirds of the patient population in the trial will receive IMC-1121B plus docetaxel, a drug approved by the FDA as a standalone or combination ...
VIVUS Completes Enrollment in the Third Phase 3 CONQUER (OB-303) Trial Business Wire (press release)
all 18 news articles »  IMCL - VVUS
Source: Google News

… HER-2/neu Status of Breast Cancers Using the United States Food and Drug Administration-Approved … -
TW Jacobs, AM Gown, H Yaziji, MJ Barnes, SJ … - Journal of Clinical Oncology, 1999 - jcojournal.org
... on formalin-fixed, paraffin-embedded samples of breast cancer. ... CA) has recently been
approved by the United States Food and Drug Administration (FDA). ...

Increased HER2 With US Food and Drug Administration-Approved Antibody -
PC Roche, JN Ingle - Journal of Clinical Oncology, 1999 - jco.ascopubs.org
... with the HercepTest than would be expected in breast cancer patients. As this antibody
system is the only one that has been FDA-approved, we report these ...

FDA Drug Approval Summary: Gefitinib (ZD1839)(Iressa (R)) Tablets -
MH Cohen, GA Williams, R Sridhara, G Chen, R … - The Oncologist, 2003 - theoncologist.org
... Under the accelerated approval regulations, the sponsor will be ... the views and findings
of the US FDA. ... of Secreted and Transmembrane Breast Cancer Markers using ...

… Drug Administration-approved Scoring and Test System of HER-2 Protein Expression in Breast Cancer -
P Birner, G Oberhuber, J Stani, C Reithofer, H … - Clinical Cancer Research, 2001 - AACR
... factor receptor (HER)-2 oncogene protein overexpression of breast cancer tissue
by the United States Food and Drug Administration (FDA)-approved HercepTest and ...

[PDF] Angiogenesis-dependent Diseases -
J Folkman - Angiogenesis, 1971 - tipregistration.com
... and breast. This result has been achieved by FDA-approved angiogenesis inhibitors.?
Roy Herbst, MD, PhD Chief of Thoracic Oncology, MD Anderson Cancer Center ...
-

… 2003 Update on the Role of Bisphosphonates and Bone Health Issues in Women With Breast Cancer -
BE Hillner, JN Ingle, RT Chlebowski, J Gralow, GC … - Journal of Clinical Oncology, 2003 - jcojournal.org
... In February 2002, the FDA approved an expanded indication for zoledronic acid that
included its use in metastatic breast cancer and multiple myeloma (www.fda ...

Velcade (R): US FDA Approval for the Treatment of Multiple Myeloma Progressing on Prior Therapy -
RC Kane, PF Bross, AT Farrell, R Pazdur - The Oncologist, 2003 - theoncologist.org
... Available online at http://www.fda.gov/cder ... food and drug administration approval
summary: bortezomib for ... B-Dependent Mechanisms in Breast Cancer Cells Regulate ...

… : Comparison of Frequently Used Assay Methods in a Molecularly Characterized Cohort of Breast Cancer … -
MF Press, DJ Slamon, KJ Flom, J Park, JY Zhou, L … - Journal of Clinical Oncology, 2002 - jco.ascopubs.org
... humanized, anti?HER-2/neu antibody, known as trastuzamab, was approved by the FDA
for treatment of women with metastatic breast cancer whose tumors ...

An economic evaluation of activated protein C treatment for severe sepsis -
BJ Manns, M Lee, C Doig, D Johnson, C Donaldson - Journal Watch Infectious Diseases, 2002 - Mass Med Soc
... A post hoc FDA analysis of the major prospective, randomized, controlled trial of ...
and chronic health evaluation (APACHE II score 25); APC was approved for use ...

Current Status of Full-Field Digital Mammography1 -
ED Pisano - Radiology, 2000 - RSNA
... The digital mammographic trials for FDA approval must now be based on the truth
regarding breast cancer status and not on the direct agreement with findings at ...

Source: Google Scholar

FDA Approves First Gene-Based Test To Detect The Spread Of Breast Cancer Into Lymph Nodes
Veridex, LLC, a Johnson & Johnson company, has announced U.S. Food and Drug Administration (FDA) approval of the first intra-operative and gene-based test to detect the spread of breast cancer into the lymph nodes. The GeneSearch(TM) Breast Lymph Node (BLN) Assay can detect the spread of cancer into the lymph nodes more accurately than existing rapid methodologies and, as a result, has the potential to reduce the need for stressful and costly second surgeries for breast cancer patients.

"Given that more than 40,000 women in the U.S. die from breast cancer annually, the demand for better medical care is extraordinarily high," said Pat Whitworth, M.D., director of the Nashville Breast Center and a principal investigator in the GeneSearch(TM) BLN clinical trials.
"With this new molecular pathology test, we have an opportunity to improve the standard of care for women with this disease. Patients and physicians now can have a higher degree of confidence in their lymph node test results and, as a result, make more informed decisions about their treatment."

The GeneSearch(TM) BLN Assay is the first in vitro diagnostic test approved in the United States for the rapid detection of metastases greater than 0.2 mm in sentinel lymph node tissue removed from breast cancer patients. In clinical trials with more than 300 patients in the U.S. that compared performance of GeneSearch(TM) with commonly performed intra-operative test procedures, GeneSearch(TM) correctly identified 95.6 percent of patients who had metastases in their lymph nodes. This high accuracy in finding metastases was statistically superior to the most commonly performed intra-operative test procedure. The new, gene-based technology of the GeneSearch(TM) test allows for the analysis of 50 percent of the sentinel node, versus five percent of tissue typically examined under a microscope for evidence of cancer cells. Test results from GeneSearch(TM) can be produced in 35 to 40 minutes during the initial surgical procedure versus two to three days with tissue pathology.

Given its level of accuracy, GeneSearch(TM) has the potential to prevent the need for costly and traumatic second surgeries for as many as 5,200 additional breast cancer patients in the U.S. each year.(1)

"Too often, women who have had breast cancer surgery are forced to return for a second operation to remove lymph nodes," said Peter Blumencranz, M.D., medical director, Breast Health Services, Morton Plant Mease Healthcare in Clearwater, Florida. "The GeneSearch(TM) BLN test has the potential to change that by more accurately guiding decisions during surgery, in real-time, thereby reducing the risks, stress, emotional trauma and costs of second surgeries."
"There is a need for a more accurate test to detect metastasized breast cancer in a woman's lymphatic tissue -- and that's where the GeneSearch(TM) BLN Assay comes in," said Ken Berlin, general manager, Veridex. "We now have the opportunity to detect some metastases that could be missed by other tests. The end result is better patient management and better patient standard of care."

Background Information

Approximately 1.2 million women in the United States have a breast biopsy performed each year. Of those, approximately 200,000 will be diagnosed with breast cancer. Axillary lymph node status is one of the most important prognostic factors for women diagnosed with the disease and impacts the choice of post surgical therapy. Surgery to remove all axillary lymph nodes for examination by the pathologist (axillary lymph node dissection or ALND) remains an integral and potentially curative component of breast cancer care. However, it is a serious procedure associated with the risk of unwanted side effects including lymphedema, restriction of arm movement and nerve complications. Until recently, most women underwent an ALND unnecessarily.(2)

To better distinguish those patients who need an ALND from those who don't, patients can now undergo a less invasive technique called sentinel lymph node biopsy (SLNB). Sentinel node biopsy involves removing only the first (sentinel) axillary lymph node that filters fluid from the breast, as this node is most likely to contain cancer cells if the cancer has begun to spread. By removing fewer lymph nodes for evaluation during an SLNB, this procedure is less invasive than complete axillary node dissection. If there is no evidence of cancer in the sentinel node, it is highly unlikely that the cancer has spread to other nodes, and there may be no need for further node removal. If the sentinel node indicates the cancer has spread, additional axillary nodes will be removed and examined.

Veridex will initiate two post-approval studies on the GeneSearch(TM) BLN Assay. The first study will further substantiate the turnaround time of the test when used intra-operatively. An additional study, which will involve more than 1,000 patients, will further validate the accuracy of GeneSearch(TM) BLN.

The GeneSearch(TM) BLN Assay, which can be performed by trained laboratory technicians, is also available in Europe. In the coming months and years, Veridex will expand the GeneSearch(TM) product platform with additional gene- based diagnostic, confirmatory, and prognostic oncology tests for breast and other cancers.

About Veridex

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch(TM) assays. http://www.veridex.com

(1)Each year, 52,000 breast cancer patients will have cancer in their lymph nodes. Using the GeneSearch(TM) BLN Assay, with a 95 percent accuracy rating, an estimated 49,400 patients could be identified as positive for cancer in the lymph nodes during their first surgery. Using the other intra- operative test, frozen section, with an estimated 85 percent accuracy rating, approximately 44,400 patients could be identified as positive during their first surgery. Therefore, on an annualized basis in the U.S., application of GeneSearch(TM) BLN Assay could prevent the need for an additional 5,200 second surgeries for breast cancer patients.

(2)Dees, EC, Shulman, LN, Souba, WW, et al. Does information from axillary dissection change treatment in clinically node-negative patients with breast cancer? Ann Surg 226:279-287, 1997.

Veridex, LLC
http://www.veridex.com
 
 
Google
Web www.iconocast.com

Search inside Iconocast for the keyword you have in mind.

Iconocast has collected more than 50,000 articles and press releases on health and science.

These are current and most up to date press releases on the subject you are searching.

We collect current health and science press releases daily from more than 5000 research and health institutes. Here is an example : The elderberry way to perfect skin

We believe if you do search inside Iconocast, you will get better results than searching the web alone.

 
 
Continue News With: News7 ; News8 ; News9 ; News9A


ADVERTISEMENT

Iconocast is about learning and teaching without borders; we offer eMarketing, Internet Advertising, Internet Marketing, Search Engine Optimization, Search Engine Marketing, Online Branding, and eMarketing News Services.

 

Iconocast Home Page

Contact Iconocast

© 2003-07. ICONOCAST is a trademark of iconocast.com.