ODAC Declines to Recommend Two New Drugs

BETHESDA, Md--The Oncology Drugs Advisory Committee (ODAC) declinedto recommend that the FDA approve two medications: ILEX Oncology's Zyrkamine(mitoguazone dihydrochloride) and Janssen's Liazal Tablets (liaro-zolefumarate).

ILEX Oncology sought approval of Zyrkamine for use in the treatmentof AIDS-related non-Hodgkin's lymphomas in patients who have been previouslytreated with at least one potentially curative regimen.

The company offered the results of two multicenter phase II studiesof Zyrkamine to support its request. However, after listening to presentationsby the company and by FDA staff members, the ODAC panel split by a sixto six vote over whether they were even satisfied that the lesions thatresponded 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 theILEX agent.

Janssen presented the results of two phase II studies to support approvalfor Liazal in the treatment of advanced prostate cancer in patients whorelapse after receiving first-line hormonal therapy. One study comparedLiazal with prednisone; the second, with cyproterone acetate. Unadjustedsurvival data showed that the prednisone patients faired better in thefirst study and revealed no statistically significant difference in survivalin the second trial.

Adjusted Data

In its presentation, however, the company, presented adjusted figuresderived from a Cox regression analysis of the data, which it contendedmore accurately portrayed Liazal's benefit.

The FDA reviewers and several ODAC members argued that the unadjusteddata were more reliable. "Both trials failed to demonstrate a benefitattributable to liarozole for advanced relapsed prostate cancer,"FDA biostatistician Gang Chen, PhD, commented. The committee voted unanimouslyagainst recommending the drug's approval.