Navigation Links
Centocor Ortho Biotech Statement on the FDA ODAC Opinion Regarding Trabectedin for Relapsed Ovarian Cancer
Date:7/15/2009

HORSHAM, Pa., July 15 /PRNewswire/ -- Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of trabectedin when administered with DOXIL(R) (doxorubicin HCI liposome injection) did not provide a sufficient benefit-risk profile for the treatment of relapsed ovarian cancer.

Ovarian cancer is difficult to treat and the disease often recurs in patients who previously have been treated with platinum-based therapy, underscoring the need for non-platinum treatment options. Centocor Ortho Biotech Products continues to believe trabectedin has an important role in the treatment of recurrent ovarian cancer. The company remains committed to working with the FDA to address the committee's concerns.

The committee provides non-binding recommendations based on its evaluation. The final decision regarding approval of the drug will be made by the FDA.

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 and Japan, where the product is marketed as YONDELIS(R) by PharmaMar SAU.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech redefines the standard of care in immunology, nephrology, and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Products, L.P. were consolidated in late 2008, and was renamed Centocor Ortho Biotech. Built upon a pioneering history, Centocor Ortho Biotech harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech 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.

Centocor Ortho Biotech Products, L.P. is a member of the Johnson & Johnson Family of Companies.


'/>"/>
SOURCE Centocor Ortho Biotech Products, L.P.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Centocor, Schering-Plough Revise Agreement Covering REMICADE, Golimumab
2. Centocor, Inc. Submits Application to FDA Requesting Approval of Golimumab for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
3. MEDVERSATION(TM) Website Launched by Centocor to Facilitate Physician-Patient Dialogue About Drug Benefits and Risks
4. Biologic Drugs, Particularly Centocor/Janssen-Cilags Stelara and Abbott/Eisais Humira, will Drive the Psoriasis Drug Market to $5 Billion by 2017
5. FASgen, Inc. Announces Research and License Agreement With Centocor, Inc.
6. Centocor R&D and University of Michigan Forge New Model for Academic/Industry Partnerships
7. Zimmer Holdings Offer and ORTHOsoft Directors Circular Mailed to Shareholders
8. David Ward Joins OrthoSynetics(TM) as Western Region Sales Manager
9. OrthoSynetics(TM) Opens New Data Center, Colocation Facility
10. Bone-growing nanomaterial could improve orthopaedic implants
11. Orthopedic Development Corporations TruFUSE(R) Procedure Tops 1,750 Patients in First Year
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/18/2017)... ... 2017 , ... “Three Narrow Roads”: a vivid and provocative look into the ... Dr. Burnett King Sr., is currently the pastor-teacher-visionary at Simply the WORD Church, a ... Inc., a track-and-field program geared towards youth. , King shares, “When I take time ...
(Date:8/18/2017)... ... August 18, 2017 , ... Rollon Skin Care ... skincare solutions, recently announced the launch of two new skincare products, Prache ... effective alternative to expensive plastic surgery or in-patient cosmetic dermatological procedures. , “We ...
(Date:8/18/2017)... ... ... the Snake”: an entertaining and moral-based short story about an unkind snake learning a ... Jr., a husband, father and grandfather who served as a U.S. Marine, U.S. Army ... for children and teens. My goal is to teach kids to use good judgement ...
(Date:8/17/2017)... Mass (PRWEB) , ... August 17, 2017 , ... ... use by health care organizations and considered extremely effective, very effective, or effective ... Physicians and Physician Leadership”. , NEJM Catalyst Insights Reports are based on surveys ...
(Date:8/17/2017)... ... August 17, 2017 , ... Industry CEOs, life ... for Anti-Infectives Rx. This off-the-record networking forum of the Boston Biotech Conference series ... School. , Industry leaders and decision makers will discuss issues facing the development ...
Breaking Medicine News(10 mins):
(Date:8/10/2017)... -- Physical Rehabilitation Network (PRN), acquired the long-standing outpatient rehabilitation clinic, ... . The reputable clinic will continue to be co-owned and ... staff of four clinicians. Lipkin received his doctorate in physical ... years of experience with a strong background in manual therapy. ... 10th PRN clinic in and around the Denver ...
(Date:8/7/2017)... 7, 2017 Insightin Health, provider of ... and engagement, announced the selection of Michael ... Development, effective as of February 2017. In this role, ... strategy for our clients. Wood brings with him ... and business analytics within the healthcare industry. Wood ...
(Date:8/7/2017)... Pharmacy, Inc. (NYSE: DPLO), the nation,s largest independent specialty pharmacy, ...  All comparisons, unless otherwise noted, are to the quarter ended ... Second Quarter 2017 Highlights include: Revenue ... 3.5% Total prescriptions dispensed of 220,000, compared ... 7.6% Gross profit per prescription dispensed ...
Breaking Medicine Technology: