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:5/3/2016)... 4, 2016 Research and Markets ... Stem Cell Therapy Market Outlook 2020" report to ... ) , ,Recombinant technology has improved significantly in past ... be developed in coming years. Many cancer drugs have ... cell therapies are also expected to be developed with ...
(Date:5/3/2016)... 3, 2016  Axiogenesis has acquired a major investment from Sino-German High-Tech Fund to further expand product development, strengthen ... http://photos.prnewswire.com/prnh/20160503/362921 ... ... ... ...
(Date:5/3/2016)... , May 3, 2016  As a teenager, ... contracted rheumatic fever, which damaged his heart. He continued ... But by June 2013, Shepherd,s heart was giving out ... death. On June 20, 2013, the Mesa, ... Artificial Heart (TAH-t). Like a heart transplant, the SynCardia ...
Breaking Medicine Technology:
(Date:5/3/2016)... (PRWEB) , ... May 03, 2016 , ... Healing ... help cancer patients and their families move toward recovery and is offered by creator ... today's Dr. Carol Francis Talk Radio show considering medical and healing modalities ...
(Date:5/3/2016)... ... 03, 2016 , ... For over 23 years, Doctors on Liens ... network of doctors and therapists treating personal injury patients on a lien basis. With ... Chiropractic and Rehabilitation in Santa Monica, Doctors on Liens is continuing that tradition. ...
(Date:5/3/2016)... ... May 03, 2016 , ... ... – a web application that helps people assess their risk of developing Alzheimer’s ... app will provide users a “Risk Reduction Score™” that summarizes how their lifestyle ...
(Date:5/3/2016)... ... ... Calvary Hospital recently hosted a reception to mark a new music program to ... Manning Walsh Home (MMW) in Manhattan. , During the school year, a student ... a week. The music brings a lot of joy to the patients, family members ...
(Date:5/3/2016)... Baltimore, Md. (PRWEB) , ... May 03, 2016 , ... ... devastating consequences of inappropriate or excessive levels of alcohol use. Alcohol and its ... fetal alcohol spectrum disorders to the susceptibility to strokes in those 65 years and ...
Breaking Medicine News(10 mins):