NeXstar's DaunoXome Sees US Launch

DaunoXome (daunorubicin citrate liposome injection) has been launched in the USA by NeXstar as the only first-line therapy for advanced HIV-associated Kaposi's sarcoma. The product was approved by the US Food and Drug Administration on April 8, following the agency's review of NeXstar's Phase III clinical trial comparing single-agent DaunoXome therapy to the three-drug regimen currently used to treat this condition. This is the company's first product introduction in the USA.

In the Phase III trial, conducted at 13 centers in the USA and Canada and involving 227 patients with advanced HIV-associated Kaposi's sarcoma, DaunoXome was found to have efficacy comparable to the three-drug regimen of adriamycin, bleomycin and vincristine (ABV). Average time of survival, according to the product's package insert, was 342 days for patients receiving DaunoXome therapy and 291 days for patients given ABV therapy. Side effects such as neuropathy and hair-loss were reduced significantly in the DaunoXome patients.