Navigation Links
FDA Approves New Treatment Option for Late-Stage Breast Cancer
Date:11/15/2010

SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute.  This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven's safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

For more information:

FDA: Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

NCI: Breast Cancer

http://www.cancer.gov/cancertopics/types/breast

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... 2017 Zimmer Biomet Holdings, Inc. (NYSE and ... present at the Cowen and Company 37 th ... Place on Tuesday, March 7, 2017 at 11:20 a.m. ... the presentation can be accessed at http://wsw.com/webcast/cowen38/zbh .  ... conference via Zimmer Biomet,s Investor Relations website at ...
(Date:2/24/2017)...  In conjunction with DURECT Corporation,s (Nasdaq: ... you are invited to listen to a conference call ... Tuesday, March 14, 2017 at 4:30 pm Eastern Time ... webcast of the presentation will be available by accessing ... Relations."  If you are unable to participate during the ...
(Date:2/24/2017)... 24. Februar 2017 ITL Limited, ( ... Gesundheitsbereiches, ist erfreut, für das zum 31. Dezember ... Vorjahreszeitraum exzellente Ergebnisse vorlegen zu können. Eine vollständige ... Wachstum" finden Sie hier . ... Steuern 2,12 Millionen USD (Dez. 2015: 1,04 Millionen USD; +104 %) ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... ... TaskMate Go. Core benefits and advantages built into the home office sit stand ... look and feel. Ability to gain the benefits embedded in the TaskMate Go ...
(Date:2/24/2017)... ... 2017 , ... Only two months after the official release of The Private ... (France), XO Private has initiated a second print-run of its lavish luxury travel coffee ... across when open, weighs in at more than six kilos, retails at EUR 1,000 ...
(Date:2/24/2017)... , ... February 24, 2017 , ... An in-depth computational ... the University of Pittsburgh points to eight genes that may explain why susceptibility to ... to the results of a study published today in the journal npj Schizophrenia. ...
(Date:2/24/2017)... , ... February 24, 2017 , ... The Smart Machine ... from Oxford University predict that 47 percent of all jobs in the United States ... “smart” and “successful.” The day of the aggressive know-it-all who steamrolls over colleagues is ...
(Date:2/24/2017)... ... 24, 2017 , ... With millions of Americans and people ... we all are aware of our options and are empowered with strength and ... launch of its newest edition of "Vision and Hearing" in USA Today, that ...
Breaking Medicine News(10 mins):