AEGiS-GMHC: Treatment Briefs: Liposomal KS Drugs Approved

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Treatment Briefs: Liposomal KS Drugs Approved

GMHC Treatment Issues, Vol. 10, No. 4 - April 1996

On April 8, 1996, the FDA granted NeXstar's DaunoXome full approval as first line therapy in people with advanced HIV-associated Kaposi's Sarcoma. DaunoXome is a liposomal (lipid-encapsulated) formulation of the anticancer compound daunorubicin and is similar to Doxil (liposomal doxorubicin). Doxil (from Sequus) received FDA "accelerated" approval last November for use only in people with advanced KS who could not tolerate or did not respond to standard chemotherapy. Doxil could be used "off-label" as first line therapy, too, but the comparative effectiveness of Doxil and DaunoXome is unknown.

Liposomal drugs tend to be safer and more stable in the body than standard formulations. Doxil is administered by infusion only once every three weeks, and DaunoXome is infused every other week. The drugs' main side effect is bone marrow suppression, which leads especially to low neutrophil counts.

The wholesale price of four month's worth of DaunoXome is $4,300, close to the $3,500 cost of ABV, the old standard chemotherapy combination for KS. Doxil costs about $6,400, but the longer interval between infusions considerably reduces the difference in total treatment costs.

NeXstar has a DaunoXome reimbursement hotline and indigent program that can be reached at 800/226-2056. A similar program exists for Doxil -- call 800/375-1658.

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