ROCKVILLE, Md--The FDA's Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended approval of DaunoXome (liposomal daunorubicin(Drug information on daunorubicin)) as first-line therapy for the treatment of advanced HIV-related Kaposi's sarcoma (KS). The usual treatment, a combination of Adriamycin, bleomycin(Drug information on bleomycin), and vincristine (ABV), is not well tolerated over the long haul, especially when given with antiretroviral agents (ddI, ddC, and AZT).
DaunoXome was developed by Vestar, Inc., which has since merged with NeXagen, Inc. to form NeXstar Pharmaceuticals, Inc., Boulder, Colorado.
In a prospective, randomized phase III clinical trial of 227 patients with advanced KS who had not received prior systemic chemotherapy, half the subjects were given DaunoXome, 40 mg/m² every 2 weeks, and the other half received ABV.
Average survival for the DaunoXome group was 12 months, which is at least comparable to ABV, said principal investigator Parkash S. Gill, MD, of the University of Southern California, and Michael E. Ross, MD, NeXstar's vice president for clinical and regulatory affairs.
Time to progression of disease was better with DaunoXome than with ABV, and time to treatment failure and overall response rate were the same for both the DaunoXome and ABV groups.
DaunoXome had fewer adverse effects than ABV, the company said. The alopecia, neuropathy, and fatigue seen with use of DaunoXome were all substantially less severe than the adverse effects of ABV. Subjects taking DaunoXome had less need for premedication, and they showed no excessive renal or hepatic dysfunction.
The company said that DaunoXome patients maintained their weight gain and maintained an acceptable quality of life for a longer time than did patients who received ABV therapy.