FDA Panel Rejects ILEX' Zyrkamine

ILEX Oncology has failed to win a positive recommendation for Zyrkamine(mitoguazone dihydrochloride), a second-line therapy for AIDS-related non-Hodgkin's lymphoma, from a US advisory panel. ILEX said it would be meeting with marketing partner Sanofi in the next few weeks to determine the next appropriate course of action.

The Food and Drug Administration's Oncologic Drugs Advisory Committee voted unanimously not to recommend approval, and noted that it was difficult to determine a true response rate for the drug given the lack of a control in the trials used to support the application. ILEX submitted data from two Phase II trials involving 90 patients.

Patients received two infusions of Zyrkamine in the first week, and then once every two weeks thereafter until either disease progression or a 16-week time point. Six patients had a complete response (6.7%), seven had a partial response (7.8%) and 16 patients (18%) had stable disease.