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DaunoXome Is Recommended for Approval for Kaposi's Sarcoma

July 1, 1995
Publication
Article
Oncology NEWS InternationalOncology 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.

Articles in this issue

ODAC Recommends Accelerated FDA Approval of Ethyol for Cytoprotection
House Panel Holds Hearing on Self-Referral
Health-Related Legislation
Mitoguazone Appears Promising in HIV-Associated Refractory NHL
Responses to Anti-HER2 MoAb Seen
NCI Committed to Increasing Minority Participation in Clinical Trials
MoAb May Improve Detection of Colon And Rectal Cancer
Zeneca Files NDA for Arimidex
Cord Blood is Used as Source of Stem Cells for Pediatric Transplantation
Gemcitabine/Cisplatin Shows Good Response Rate And Favorable Toxicity Profile in Advanced NSCLC
HCFA Needs to Do More to Prevent Medicare/Medicaid Fraud and Abuse
M.D. Anderson Holds First Cancer Meeting in Spanish
Molecular Markers Predict Clinical Outcome
NCAB Has Concerns About Future of Clinical Research
IP Interleukin-2 Shows Durable Responses in Ovarian Cancer

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