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ODAC Says DaunoXome Should Be Approved for HIV-Associated KS

ODAC Says DaunoXome Should Be Approved for HIV-Associated KS

ROCKVILLE, Md--The FDA's Oncologic Drugs Advisory Committee (ODAC)
has unanimously recommended approval of DaunoXome (liposomal daunorubicin)
as first-line therapy for the treatment of advanced HIV-related
Kaposi's sarcoma (KS). The usual treatment, a combination of Adriamycin,
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.

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