Liposome Technology's DOX-SL

19 December 1994

Liposome Technology Inc's liposomal doxorubicin product DOX-SL should be reviewed by the Food and Drug Administration's Oncologic Drugs Advisory Committee in first-quarter 1995, according to chief financial officer Peter Leigh. Approval is being sought to market the drug for Kaposi's sarcoma.

The New Drug Application for DOX-SL was filed in September and includes results of Phase II studies involving 400 patients with KS. Response rates of over 75% were achieved. LTI is also developing DOX-SL for non-small cell lung cancer, liver, ovarian and breast cancers and soft tissue carcinomas (Phase II).

Last year, Vestar's submission for approval of its similar product Dauno-Xome was rejected by the FDA panel, which concluded that Phase II data submitted in support of the application were insufficient to warrant approval.

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