Navigation Links
Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer
Date:11/20/2008

BRIDGEWATER, N.J., Nov. 20 /PRNewswire/ -- Ortho Biotech Products, L.P. today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection)for the treatment of women with relapsed ovarian cancer (ROC). If approved, trabectedin combined with DOXIL will provide a new, non-platinum treatment option for these patients in the United States.

The application follows the completion of a multicenter, randomized Phase III study, ET743-OVA-301, one of the largest studies conducted in ROC, comparing the combination of trabectedin and DOXIL to DOXIL alone in 672 patients. The study showed that patients treated with the combination treatment had a statistically significant improvement in the primary endpoint of progression-free survival (PFS, or the length of time during and after treatment in which the disease does not progress) compared to patients treated with DOXIL alone.

"This is a significant milestone in the development of trabectedin, an agent with a novel mechanism of action that holds promise for patients with relapsed ovarian cancer," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/ Nephrology, Ortho Biotech Products, L.P. "We are confident in the strength of the data supporting the application and look forward to working with the FDA throughout the regulatory review process."

Relapsed ovarian cancer refers to epithelial carcinoma of the ovary that recurs after treatment. According to the National Cancer Institute (NCI), it is estimated that 21,650 women will be diagnosed with, and 15,520 women will die from ovarian cancer in the U.S. in 2008.

Trabectedin is being developed under a license from PharmaMar, and DOXIL is marketed by Ortho Biotech Products, L.P. in the U.S.

About t
'/>"/>

SOURCE Ortho Biotech Products, L.P.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. New Orthopedic Oncology Fellowship Program at Mount Clemens Brings Highly Trained Surgeons to State
2. Ferring Pharmaceuticals Promotes William Garbarini to Vice President of New Orthopaedics and Urology Business Unit
3. Dental Implants Effective for Orthodontic Treatment
4. Hanger Orthopedic Group, Inc. Receives Favorable New Code for WalkAide
5. Zimmer Holdings to Collaborate with the American Orthopaedic Association for Funding Post-Graduate Medical Education
6. Dr. Ron Greenspan has Been Selected for the 2008 Best of San Diego Award in the Orthodontists Category by the U.S. Local Business Association
7. Orthodontists Offer Sweet Incentives for Tricky Halloween Treats
8. Hanger Orthopedic Group, Inc. Exceeds Estimates on a 10% Sales Increase and a 28% EPS Increase to $0.23 for the Third Quarter 2008
9. Archus Orthopedics Performs First Facet Replacement Procedure With an Artificial Disc
10. Hanger Orthopedic Group, Inc. Announces Underwritten Public Offering by Shareholder
11. Amy Street, Certified Prosthetist and Orthotist, Joins BridgePoint Medical Partner, Charlotte Orthotic and Prosthetic Center (COPC)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... 2014 Until now, those with leg or ... walkers to keep mobile. Thanks to an inventor from Suffolk, ... effective. , He developed a prototype for the patent-pending SUPPORT ... or foot but provide comfort and reduce pain for those ... it is also convenient and easy to install on the ...
(Date:8/22/2014)... 265,000 Danes are acutely admitted to medical departments with ... and Aarhus University Hospital now shows that many of ... are sent home again without receiving a diagnosis of ... "Naturally, there is no need for a diagnosis if ... a serious illness. So some patients will always be ...
(Date:8/22/2014)... intolerance. However, these are two entirely different mechanisms that ... not digest lactose properly because they lack an enzyme ... much more dangerous cow milk allergy, however, the body,s ... antibodies. , According to statistics, about two to three ... milk allergy. Less adults are diagnosed with the disease. ...
(Date:8/22/2014)... (PRWEB) August 22, 2014 The ALS ... the ALS Center at Allegheny Health Network ... Center, based at Allegheny General Hospital (AGH), is the ... the ALS Association for meeting the highest levels of ... amyotrophic lateral sclerosis (ALS), often referred to as Lou ...
(Date:8/22/2014)... 21, 2014 (HealthDay News) -- The air in American ... Protection Agency reported Thursday. Significant progress has been ... air in recent decades, the agency said in a ... nearly 60 percent reduction in mercury from human sources ... benzene, and an 84 percent fall in lead, which ...
Breaking Medicine News(10 mins):Health News:Assistive Device for Walking Invented by InventHelp Client (VBL-501) 2Health News:Many patients are discharged without a diagnosis 2Health News:Scientists uncover why major cow milk allergen is actually allergenic 2Health News:Allegheny Health Network ALS Program Named Certified Treatment Center of Excellence 2Health News:Allegheny Health Network ALS Program Named Certified Treatment Center of Excellence 3Health News:Air in U.S. Cities Getting Cleaner, EPA Says 2
... Sept. 14 The following is a,Statement by Oscar S. Wyatt, Jr.: "I,ve seen some ... politicians who want to,return those funds received from me, please return them in the form of ... ... Medical Foundation ...
... Amylin Pharmaceuticals,Inc. (Nasdaq: AMLN ) management will be ... 43rd Annual Meeting of the European,Association for the Study ... a.m. PT / 1:30 p.m. CET local time in ... and recordings will be made,available following the event. The ...
... defects, U.S. experts say , , FRIDAY, Sept. 14 (HealthDay News) ... women since the federal government mandated folate fortification to prevent ... is enough -- or too much. , A new study ... finds that the number of women of childbearing age who ...
... Most people looking for tax advice,usually go to ... right? Here,s more on a new report that shows ... are actually not seeing the pros,trained in their field. ... Registered journalists can access video, audio, text, ...
... Blue Cross and Blue,Shield Association (BCBSA) convened a ... D.C., to discuss how insurers, doctors and hospitals,are ... safety.,Representatives from the Premier Inc. healthcare alliance, Duke ... Alabama, and WellPoint, Inc.,participated in the event. ...
... between the two protective treatments , FRIDAY, Sept. 14 (HealthDay ... a pill called dabigatran etexilate (DE) is just as effective ... blood clots after total hip replacement surgery. , As reported ... study included almost 3,500 hip replacement patients who received either ...
Cached Medicine News:Health News:Women's Folic Acid Levels Improving 2Health News:Women's Folic Acid Levels Improving 3Health News:Women's Folic Acid Levels Improving 4Health News:Blue Cross and Blue Shield Association Holds Forum to Explore Patient Safety and Healthcare Quality Initiatives 2Health News:Blue Cross and Blue Shield Association Holds Forum to Explore Patient Safety and Healthcare Quality Initiatives 3Health News:Blue Cross and Blue Shield Association Holds Forum to Explore Patient Safety and Healthcare Quality Initiatives 4Health News:Pill Equals Injection in Preventing Clots After Hip Replacement 2
(Date:8/21/2014)... Aug. 21, 2014 /CNW/ - The Canadian Epilepsy Alliance (CEA) ... series designed to educate children about the most common neurological ... Medikidz Explain Epilepsy comic series tells a fictional story ... middle school while living with epilepsy. "Despite ... is still so much misinformation and lack of awareness out ...
(Date:8/21/2014)... , Aug. 21, 2014  Seventy-one percent of Americans believe ... is a serious public health and safety issue in ... a survey released today by Repass & Partners, a ... "Americans understand the severity of the prescription medication abuse ... with this very serious health situation facing our country," ...
(Date:8/21/2014)... , Aug. 21, 2014 InfinityQS International, ... Manufacturing Intelligence , today announces Infusion Chicago, ... event will be held Oct. 9-10, 2014, at ... designed to showcase the necessity for implementing a ... and Manufacturing Intelligence to gain insight into production ...
Breaking Medicine Technology:Action Heroes Harness Powers to Educate Children About Epilepsy 2Action Heroes Harness Powers to Educate Children About Epilepsy 3Consumers Desperate For Measures To Curb Prescription Drug Abuse 2Consumers Desperate For Measures To Curb Prescription Drug Abuse 3InfinityQS to Host Manufacturing Intelligence Conference in Chicago 2
... Durable ergonomic chairs with concave seats ... • Select options like seats, backrests, ... Choose the BE Series for top ... including: industry, education, laboratory, clean room, ...
... with concave seats and large backrests ... like seats, backrests, armrests, and casters ... Series for top performance in a ... laboratory, clean room, static control, health ...
... chairs with concave seats and large backrests ... seats, backrests, armrests, and casters and glides. ... performance in a variety of environments including: ... health care and office. • With tubular ...
Contoured waterfall-front ergonomic seats and generous backrests with lumbar support are standard on these ergonomic chairs. • With casters • With Tubular Base....
Medicine Products: