BETHESDA, Md--The Oncology Drugs Advisory Committee (ODAC) declined
to recommend that the FDA approve two medications: ILEX Oncology's Zyrkamine
(mitoguazone dihydrochloride) and Janssen's Liazal Tablets (liaro-zole
ILEX Oncology sought approval of Zyrkamine for use in the treatment
of AIDS-related non-Hodgkin's lymphomas in patients who have been previously
treated with at least one potentially curative regimen.
The company offered the results of two multicenter phase II studies
of Zyrkamine to support its request. However, after listening to presentations
by the company and by FDA staff members, the ODAC panel split by a six
to six vote over whether they were even satisfied that the lesions that
responded to the drug in the two studies were actually non-Hodgkin's lymphomas.
The committee unanimously voted not to back a new drug approval for the
Janssen presented the results of two phase II studies to support approval
for Liazal in the treatment of advanced prostate cancer in patients who
relapse after receiving first-line hormonal therapy. One study compared
Liazal with prednisone; the second, with cyproterone acetate. Unadjusted
survival data showed that the prednisone patients faired better in the
first study and revealed no statistically significant difference in survival
in the second trial.
In its presentation, however, the company, presented adjusted figures
derived from a Cox regression analysis of the data, which it contended
more accurately portrayed Liazal's benefit.
The FDA reviewers and several ODAC members argued that the unadjusted
data were more reliable. "Both trials failed to demonstrate a benefit
attributable to liarozole for advanced relapsed prostate cancer,"
FDA biostatistician Gang Chen, PhD, commented. The committee voted unanimously
against recommending the drug's approval.