A Issues Complete Response Letter For Trabectedin Combined With DOXIL
HORSHAM, Pa., Sept. 10 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P.
today announced that it received a Complete Response letter from the U.S. Food
and Drug Administration (FDA) regarding the New Drug Application (NDA) for
trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI
liposome injection) for the treatment of women with relapsed ovarian cancer.
The agency has requested additional information, including overall survival
data from the company's ongoing pivotal trial and additional clinical
Centocor Ortho Biotech Products continues to believe that trabectedin has an
important role in the treatment of patients with ovarian cancer. The company
is reviewing the FDA's letter and will respond to the agency's questions as
quickly as possible.
The NDA for trabectedin was submitted to the FDA in November 2008.
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 as YONDELIS(R) by PharmaMar SAU and
Japan, where PharmaMar SAU and Taiho Pharmaceutical CO., LTD. have a licensing
agreement to develop and commercialize YONDELIS.
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.
SOURCE Centocor Ortho Biotech Products, L.P.
Media, Lisa Vaga, +1-908-218-7316, Mobile, +1-908-670-0363, [email protected],
or Investors, Louise Mehrotra, +1-732-524-6491, Tina Pinto, +1-732-524-2034