NeXstar's DaunoXome Slated For FDA Committee Review In June

NeXstar's amended New Drug Application for DaunoXome (liposomal daunorubicin), for the second-line treatment of Kaposi's sarcoma in HIV-infected patients, is scheduled for review by the US Food and Drug Administration's Oncologic Drugs Advisory Committee on June 8 to 9, reports the company. The panel voted against approval of the product based on Phase II data in June 1993, so NeXstar submitted Phase III results in January.

The Phase III study compared DaunoXome to a combination regimen of doxorubicin, bleomycin and vincristine in 232 patients with KS. Preliminary data on 115 patients (to be presented at the American Society of Clinical Oncology meeting in June) show that at a dose of 40mg/m2, DaunoXome is as effective as the triple regimen but with fewer side effects, such as alopecia, insomnia and neuropathy. Both regimens were given intravenously every two weeks until progression.