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:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... Cary, North Carolina (PRWEB) , ... June 26, 2016 , ... ... the release of a new product that was developed to enhance the health of ... harvested for centuries. , The two main herbs in the PawPaws Cat Kidney ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... health policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, ... work on several important health care topics including advance care planning, healthcare costs ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
Breaking Medicine Technology: