Immunex Corp.'s Novantrone received a vote of confidence forexpanded use when an FDA advisory committee Wednesdayacknowledged the chemotherapeutic drug has demonstrated clinicalbenefit for late-stage prostate cancer patients.
The Oncologic Drugs Advisory Committee (ODAC) action movesNovantrone a step closer to approval as the first therapy for prostatecancer patients who have failed other forms of the treatment andwhose median survival is about a year.
Novantrone (mitozantrone) has been on the market in the U.S. since1987 for acute myelogenous leukemia. Immunex's annual sales totalbetween $40 million and $45 million.
More than 300,000 new cases of prostate cancer are diagnosed eachyear and the disease is the second leading cause of cancer death inmen. An estimated 40,000 to 60,000 patients have late-stage prostatecancer.
Those patients, said Peggy Phillips, Immunex's senior vice presidentof pharmaceutical development, experience severe pain and asignificantly diminished quality of life from the spread of the cancer.
Phillips said pivotal clinical trials in Canada and the U.S.demonstrated Novantrone, in combination with prednisone,significantly relieved pain, improved quality of life and delayedprogression of the disease.
Phillips added, however, the studies did not demonstrate Novantroneincreased survival.
In the Canadian trials, which were conducted between 1990 and1994, 161 patients were enrolled and they received either Novantroneand prednisone or prednisone alone. The data, Phillips said, showedpatients receiving the combination therapy experienced pain relief sixmonths longer and their cancer took twice as long to progress.
In the U.S. study, she said, patients were not as ill as those in theCanadian trials. The results demonstrated Novantrone relieved painand improved quality of life, but the drug did not show it extendedsurvival.
The favorable ODAC assessment of Novantrone came four monthsafter Immunex filed to expand the label. The drug was consideredunder the FDA's accelerated review guidelines for cancer treatments.
Immunex, of Seattle, acquired Novantrone from American CyanamidCo., of Wayne, N.J., which purchased a majority interest in Immunexin 1993. American Home Products Corp., of Madison, N.J., boughtCyanamid in 1994.
Immunex sells Novantrone in the U.S. American Home Products sellsthe drug in Europe for acute myelogenous leukemia, but has not yetfiled for European market clearance for prostate cancer.
Immunex's stock (NASDAQ:IMNX) closed Wednesday down$0.875 to $13. n
-- Charles Craig
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