DaunoXome Is Recommended for Approval for Kaposi's Sarcoma

Oncology NEWS International Vol 4 No 7, Volume 4, Issue 7

BOULDER, Colo--NeXstar Pharmaceuticals, Inc. has announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended approval of DaunoXome, NeXstar's liposomal formulation of daunorubicin, as first-line therapy for Kaposi's sarcoma. ODAC made its recommendation upon review of the company's amended NDA, which included data from NeXstar's phase III study of 227 HIV-positive patients with advanced Kaposi's sarcoma.

BOULDER, Colo--NeXstar Pharmaceuticals, Inc. has announced thatthe FDA's Oncologic Drugs Advisory Committee (ODAC) has recommendedapproval of DaunoXome, NeXstar's liposomal formulation of daunorubicin,as first-line therapy for Kaposi's sarcoma. ODAC made its recommendationupon review of the company's amended NDA, which included datafrom NeXstar's phase III study of 227 HIV-positive patients withadvanced Kaposi's sarcoma.