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Pa., April 29, 2011 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P., today announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin for the treatment of women with recurrent ovarian cancer (ROC).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 commercial
'/>"/>

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

Page: 1 2

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:8/22/2014)... , Aug. 22, 2014 Today, ... that modify the religious "accommodation" but still require ... that have an abortifacient effect, including Plan B ... after pill"). The Obama Administration also announced that ... closely held, for-profit corporations. The regulations ...
(Date:8/22/2014)... Aug. 22, 2014  Dr. Mark Rasak , ... Diamond Lifetime Achievement Award in the field of Medicine ... Cardiovascular Clinical Associates. Dr. Rasak has over ... major aspects of the business; overseeing the daily operations; ... coronary intervention. In addition, he is an honored Fellow ...
(Date:8/22/2014)... Cali ., Aug. 22, 2014  Research ... shows that a therapy being developed by Hera Therapeutics Inc. ... cause 70 percent of all cervical cancer. When ... replication of HPV-16, HPV-18 and HPV-11 cells, according to ... Ph.D., who presented the findings at the Seattle ...
Breaking Medicine Technology:Liberty Institute: Government "Accommodation" Still Requires Employers To Facilitate Coverage Of Abortifacient Drugs 2Dr. Mark Rasak, MD is recognized by Continental Who's Who with the Diamond Lifetime Achievement Award 2Study shows Hera Therapeutics experimental compound shuts down human papillomavirus that causes most cervical cancer 2
... At its regularly scheduled meeting on September 14, ... (the "Company" or "AMPAC") (Nasdaq: APFC ) ... that shareholders at the next Annual Meeting amend AMPAC,s ... for director election with a simple majority vote requirement. ...
... U.S. Food and Drug Administration (FDA), working in close ... announced that Forest Pharmaceuticals, Inc. entered into a plea ... actions including distribution of an unapproved new drug, distribution ... inspection. (Logo:   http://photos.prnewswire.com/prnh/20090824/FDALOGO ) ...
Cached Medicine Technology:American Pacific Adopts Corporate Governance Changes 2Forest Pharmaceuticals Agrees to Guilty Plea for Violating FDA Laws 2Forest Pharmaceuticals Agrees to Guilty Plea for Violating FDA Laws 3
(Date:8/23/2014)... 23, 2014 Legal Insider Bot ... by Greg Marks has been generating a buzz of ... The commotion surrounding the new product has drawn the ... , “In recent years the market has ... commonly referred to as robots or ‘bots,'” reports Hendricks. ...
(Date:8/23/2014)... GBI Research, the leading business intelligence ... in Major Developed Markets to 2020 - New and ... which provides in-depth analysis of the critical care market ... and Canada. The report provides an estimation of market ... It covers critical care indications that are being treated ...
(Date:8/23/2014)... August 23, 2014 Professional kitchen employees, ... study aid in preparing for Food Safety Certification exams ... by Dynamic Path. , Dynamic Path announced the ... includes more than 200 review questions for culinary industry ... designed to cover requirements of the ServSafe® Food Safety ...
(Date:8/23/2014)... (PRWEB) August 23, 2014 Young adults in Athens, ... doing drugs should pick up the phone and call the new ... teen drug addict . , Troubled Teen Athens is a ... ready to finally take the necessary steps to end substance abuse ... are quick to go to friends or peers when really they ...
(Date:8/23/2014)... 23, 2014 Youth substance abuse is ... no different in Houston, TX. Substance abuse can happen ... to drug and alcohol dependency in higher numbers than ... beat substance abuse, but don’t know where to find ... can be a challenge because most treatment options are ...
Breaking Medicine News(10 mins):Health News:Legal Insider Bot Review Examining Greg Marks’ Trading Software Released 2Health News:Critical Care Therapeutics in Major Developed Markets to 2020 | Researchmoz 2Health News:Critical Care Therapeutics in Major Developed Markets to 2020 | Researchmoz 3Health News:Food Handler Safety Certification Made Easy with Dynamic Path 2Health News:Teenagers in Athens, GA are Locating Addiction Recovery Thanks to New Helpline 2Health News:New Houston Hotline Assisting Juveniles in Locating Dependable Rehabilitation Help 2
... of the population but account for nearly 20 percent ... major risk factor for // suicide in the elderly. ... thoughts in depressed elderly patients. ,Researchers from ... 600 elderly patients with depression. Some patients were assigned ...
... skin’s worst enemies, but now some dermatologists are taking cues from sunlight ... phototherapy. ,Standing in front of a UV light is ... from a disease called morphea , it can affect any area of ... joints, also known as localized scleroderma. She says: “I had a bunch ...
... can be a significant predictor of breast cancer risk for ... ,In 1992, researchers sampled nearly 62,000 women, ages ... age 18 and their current weight. Since then, the women ... in addition to any diagnosis of cancer. Research shows ...
... Around 165,000 cases of lung cancer are diagnosed in ... to 25 percent are classified // as small cell ... and the disease frequently travels to the brain and ... cancer, for example, ranges up to 80 percent. Whether ...
... a new drug is showing promising results.For the past ... recombinant immunotoxins. An immunotoxin is bioengineered and consists of ... antibodies that are commonly used to fight leukemia. One ... a phase II study. ,Researchers say in a ...
... A recent study has shown that a chemotherapy regimen ... prednisone is effective in the treatment of hormone-refractory prostate ... to symptomatic patients earlier in their disease. ... study of this treatment regimen is planned. From a ...
Cached Medicine News:Health News:A Combination Of Drugs Effective In The Treatment Of Hormone-Refractory Prostate Cancer 2
Sterile cordless eraser tips, packsize is 10/box....
Hydroview insertion forcep with very thin jaws to allow insertion through tunnel or clear cornea incision. Locking. Made in titanium....
Bi-angled insertion jaws designed to enhance surgeon comfort and efficiency. Reverse action releases lens when handle is compressed. Made in titanium....
45 degree. Angled shafts. Tip to angle length: 11.5 mm. Stops in handle designed to prevent "over folding". Manufactured in titanium....
Medicine Products: