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Firstapproval forHposomaldaunombicin

NeXstar's liposomal daunorubicin product'DaunoXome' has received its first approval as aprimary therapy for AIDS-related Kaposi's sarcomafrom the Swedish Medical Products Agency.'DaunoXome' will be marketed in Sweden shortly,reports Marketletter.'

Liposomal daunorubicin has also been recom­mended by the US FDA's Oncological DrugsAdvisory Committee for approval as a first-linetherapy for advanced AIDS-related Kaposi's sarcoma,according to the Pink Sheet.' This recommendation isbased on the results of randomised trials conducted byNeXstar and included in the company's amendedNDA. The largest of these trials compared liposomaldaunorubicin therapy with combination therapy thatcomprised doxorubicin [adriamycin], bleomycin andvincristine.

NeXstar originally submitted an NDA for'DaunoXome' in 1993, but this was rejected by theFDA because of insufficient data.1. NeXstar gains first approval for Daunoxome. Marketlener. 23, 12 Jun 1995

2. NeXstar DaunoXome recommendation for first-line use in advanced Kaposi'ssarcoma boosted by randomized trial ; effieaey and toxicity comparable to ABV.

FDC Reports - Pink Sheet; 5-6, 12 Jun 1995 1003'''''''

24Jun1995INPHARMAa 0156-270319510992-000221$01 .OocAdis International Llmltad 1995. All rights reserved