Keeping Track of Doxil

by Vernal Branch

When the Oncologic Drug Advisory Committee (ODAC) voted in July to overwhelmingly advise against approval of Doxil for metastatic breast cancer, that wasn’t the end of the story.

The ODAC makes recommendations to the commissioner of the Food and Drug Administration, who has the final decision about whether to approve this use for the drug. While it unusual for the commissioner to reject an ODAC recommendation, especially when most of the ODAC members are of the same opinion, it’s not completely unheard of.

The entire process of approval or rejection can take from six to 10 months and will result in either a new label for the drug—allowing its use in metastatic breast cancer—or a detailed letter to Ortho Biotech about what the company would need to do before it could bring the issue of approval back to the FDA. If such a letter is issued, the only way to get a copy is to ask the company for it. The FDA cannot release it.

If approval is denied, Ortho Biotech can appeal that decision internally at the FDA. The appeal procedure is not public.

BCA is continuing to follow the Doxil story, and we are in touch with Ortho Biotech about its next steps with the drug.

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