FDA’s ODAC, or its oncological drug advisory committee, met on July 15, 2009, to discuss, among other matters, a request to approve a combination-therapy indication — for advanced breast cancers — on a drug sold worldwide, by Schering-Plough under the name of Caelyx. According to PR Canada.net, the outcome was decidedly unfavorable to Centocor-Ortho, and thus Schering-Plough:
. . . .Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of Doxil (doxorubicin HCI liposome injection) and docetaxel did not provide a sufficient benefit-risk profile for the treatment of women with locally advanced or metastatic breast cancer. . . .
Doxil is marketed in the United States by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as Caelyx throughout the rest of the world, excluding Japan and Israel. . . .
[From the FDA's ODAC meeting materials:]
. . . .Doxil [Caelyx] is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. . . . Doxil [Caelyx] is also indicated for the treatment of AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. . . .
So, it is not likely that FDA will approve Caelyx — for these expanded breast cancer indications, when the full commission next meets. It is also noteworthy that the putative benefit-to-risk profiles of a given drug, or combination — are cited as the basis for non-approvability — more explicitly, in the written records of FDA, of late.
