Novantrone Scheduled For Review Next Month
Immunex' advanced prostate cancer treatment Novantrone (mitoxantrone) will come up against the US Food and Drug Administration's Oncologic Drugs Advisory Committee on September 11. It is already approved in the USA for use in acute non-lymphocytic leukemia.
The firm's supplemental New Drug Application for mitoxantrone has been granted priority review status by the FDA because of the dearth of effective treatments available for prostate cancer. This means that the FDA will review the application in six months rather than 12. Immunex filed the sNDA in May.
Mitoxantrone is an anthracenedione similar in structure to the anthracyclines (doxorubicin and idarubicin), but which lacks an amino sugar component that is thought to contribute to the cardiotoxicity characteristic of the anthracyclines.
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