Navigation Links
Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin
Date:4/29/2011

HORSHAM, Pa., April 29, 2011 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P., today announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin for the treatment of women with recurrent ovarian cancer (ROC).  The withdrawal is based on the U.S. Food and Drug Administration's (FDA) recommendation that an additional Phase 3 study be conducted to obtain approval.

The NDA was submitted to the FDA in November, 2008.  The FDA issued a Complete Response letter in September 2009 and requested additional information, including overall survival data from the pivotal OVA-301 trial and additional clinical pharmacology studies.  

The OVA-301 overall survival data will be the subject of a poster presentation on June 5, 2011 at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

The company is evaluating the development program for YONDELIS in recurrent ovarian cancer.

Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., recently initiated a Phase 3 study (SAR-3007) with trabectedin for metastatic L-sarcoma (liposarcoma or leiomyosarcoma).

About Trabectedin

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata.  The compound is now produced synthetically.  Trabectedin binds to the minor groove of DNA and bends it toward the major groove, causing DNA adducts that interfere with cell division and genetic transcription processes and DNA repair machinery.  

Under a licensing agreement with PharmaMar SAU of Spain, Centocor Ortho Biotech Products, L.P., has worldwide marketing rights for trabectedin except in Europe, where the product is marketed by PharmaMar SAU and Japan, where PharmaMar SAU and Taiho Pharmaceutical CO., LTD. have a licensing agreement to develop and commercialize it.  In countries where it has received marketing authorization, trabectedin is marketed as YONDELIS®.

Trabectedin is approved in more than 63 countries globally.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech Products, L.P., a Johnson & Johnson Company, redefines the standard of care in immunology, nephrology, and oncology.  Built upon a pioneering history, Centocor Ortho Biotech Products harnesses innovations in large and small molecule research to create important new therapeutic options.  Beyond its innovative medicines, Centocor Ortho Biotech Products is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care.  


'/>"/>
SOURCE Centocor Ortho Biotech Products, L.P.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Court of Appeals Overturns $1.8 Billion Patent Verdict for Centocor Ortho Biotech Inc.
2. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
3. Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastatic Advanced Prostate Cancer
4. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label to Include Inhibition of Structural Damage in Treatment of Psoriatic Arthritis
5. Despite Managed Care Obstacles, Interest and Anticipated Use of Centocor Ortho-Biotechs New Psoriasis Agent Stelara (ustekinumab) is High
6. Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
7. Hanger Orthopedic Group Reports First Quarter Results
8. Johnson & Johnson and Synthes Announce Definitive Merger Agreement to Create Worlds Most Innovative and Comprehensive Orthopaedics Business
9. Daiichi Sankyo Receives First Market Approval in Japan for LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, for the Prevention of Venous Thromboembolism after Major Orthopedic Surgery
10. ORTHOCON® Receives CE Mark and Health Canada Medical Device License for HEMASORB®
11. Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... , Feb. 4, 2016   Bernstein Liebhard LLP ... filed in the United States District Court for the District ... class (the "Class") consisting of all persons or entities who ... "Company") (NASDAQ: INSY ) from March 3, 2015 through ... and certain of its officers with violations of the Securities ...
(Date:2/4/2016)... Feb. 4, 2016 Summary Breast cancer, ... and the most common cancer in women worldwide, accounting ... exceedingly prevalent. The number of women diagnosed with breast ... the number of deaths has declined due to earlier ... has been revolutionized in the past four decades, especially ...
(Date:2/4/2016)... Feb. 4, 2016 Mettler-Toledo International Inc. (NYSE: ... 2015.  Provided below are the highlights: , ... compared with the prior year.  Reported sales decreased 3% ... quarter. , Net earnings per diluted share as ... prior- year period.  Adjusted EPS was $4.65, an increase ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... February 06, 2016 , ... ... EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , WHAT:     , This conference ... estimated 5000 perioperative nurses in attendance to study the latest evidence-based recommendations ...
(Date:2/6/2016)... ... ... Shark Finds and Kevin Harrington, along with the Product Managers ... Belly Bands. , Having a dog is great—except when it wets every couch, bed, ... works, get Belly Bands, the easiest way to stop dogs from wetting on ...
(Date:2/5/2016)... NY (PRWEB) , ... February 05, 2016 , ... Love ... long-stem roses in a variety of colors, assortments and packaging. This staple for Valentine’s ... any King Kullen location. , For Valentine’s Day, not only are long-stem roses ...
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment ... new clinical and scientific initiatives have all marked the last 12 months at ... and CEO of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco Canales, MD and ... their Napa Valley office. The technique utilizes the body’s own healing abilities to ... Dr. Furnas, are part of only a select few cosmetic surgeons bringing this ...
Breaking Medicine News(10 mins):