FDA issues approvable letter for DaunoXome.BOULDER, Colo.--(BUSINESS WIRE)--July 13, 1995--NeXstar Pharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :NXTR) announced today that it has been advised by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) that the company's anticancer drug, DaunoXome, is approvable as a first-line cytotoxic therapy for the treatment of advanced, HIV-associated Kaposi's sarcoma. The FDA's letter is a critical step toward final marketing approval for DaunoXome, the company's liposomal formulation of the anticancer agent, daunorubicin daunorubicin /dau·no·ru·bi·cin/ (daw?no-roo´bi-sin) an anthracycline (q.v.) antibiotic used as an antineoplastic; administered as the hydrochloride salt or as a liposome-encapsulated preparation of the citrate salt. . In June, the Swedish Medical Products Agency approved DaunoXome for the treatment of advanced Kaposi's sarcoma. NeXstar presented data from its phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the at the Oncologic Drugs Advisory Committee on June 8. The company's phase III trial, completed in September 1994, was a controlled, randomized study of 227 HIV-positive patients with advanced Kaposi's sarcoma. The study compared the efficacy and side effects profile of DaunoXome and a three-drug regimen of adriamycin, bleomycin bleomycin /ble·o·my·cin/ (ble-o-mi´sin) a polypeptide antibiotic mixture obtained from cultures of Streptomyces verticellus; used as the sulfate salt as an antineoplastic. ble·o·my·cin n. and vincristine vincristine /vin·cris·tine/ (vin-kris´ten) an antineoplastic vinca alkaloid; used as the sulfate salt in the treatment of various neoplasms, including Hodgkin's disease, acute lymphocytic leukemia, non-Hodgkin's lymphoma, Kaposi's (ABV). Based on its review, the Advisory Committee recommended that DaunoXome should be approved as a first-line therapy. "We are delighted with FDA's decision to issue this approvable letter," said Michael E. Ross, M.D., NeXstar's vice president for medical and regulatory affairs. "DaunoXome represents an important option as the initial therapy for controlling advanced Kaposi's sarcoma in HIV-positive patients." NeXstar Pharmaceuticals Inc. is an integrated pharmaceutical company engaged in the discovery, development, manufacturing and marketing of products to treat life-threatening diseases. The company has headquarters in Boulder, research, development and manufacturing facilities in Boulder, San Dimas, Calif., and Antwerp, Belgium, and marketing subsidiaries in several European countries. CONTACT: NeXstar Pharmaceuticals, Boulder Joseph Alper, 303/546-7717 |
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