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ODAC Declines to Recommend Two New Drugs

ODAC Declines to Recommend Two New Drugs

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 fumarate).

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 ILEX agent.

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.

Adjusted Data

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.

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