Wednesday, July 15, 2009
Market Report -- In Play (JNJ): Trabectedin (Yondelis)
Market Report -- In Play (JNJ): Briefing.com Business News - MSN Money: "Johnson & Johnson: Centocor Ortho Biotech issues statement on the FDA ODAC opinion regarding trabectedin for relapsed ovarian cancer Co announces based on the data presented today, the FDA Oncologic Drugs Advisory Committee recommended that the combination of trabectedin when administered with DOXIL did not provide a sufficient benefit-risk profile for the treatment of relapsed ovarian cancer. 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."
FDA panel recommends against Centocor’s trabectedin (ovarian cancer)
The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted Wednesday not to recommend approval of trabectedin, an experimental cancer treatment being developed by Centocor Ortho Biotech.
Centocor Ortho Biotech of Horsham, Pa., is seeking approval of trabectedin as part of a combination therapy with the cancer drug Doxil for patients with relapsed ovarian cancer.
FDA committee recommendations are nonbinding, but the federal agency generally follows the advice of its advisory panels when making a final determination......Under a licensing agreement with PharmaMar SAU of Spain, Centocor has worldwide marketing rights for trabectedin except in Europe and Japan, where the product is marketed as Yondelis by PharmaMar.
Methylation and protein expression of DNA repair genes: association with chemotherapy exposure and survival in sporadic ovarian and peritoneal carcinomas
Abstract | Methylation and protein expression of DNA repair genes: association with chemotherapy exposure and survival in sporadic ovarian and peritoneal carcinomas: "Methylation and protein expression of DNA repair genes: association with chemotherapy exposure and survival in sporadic ovarian and peritoneal carcinomas"
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