If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  DaunoXome Approved by FDA As First-line Therapy For Kaposi's Sarcoma BOULDER, Colo. April 10, 1996 -- NeXstar Pharmaceuticals, Inc. (NASDAQ:NXTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's anticancer drug DaunoXomeb (daunorubicin citrate liposome injection) as a first-line cytotoxic therapy for the treatment of advanced, HIV-associated Kaposi's sarcoma. The Company plans to launch DaunoXomeb shortly at a price competitive with conventional therapy. DaunoXomeb is formulated to maximize the selectivity of daunorubicin for solid tumors in the body. In granting approval for DaunoXomeb, the FDA noted that the drug was as effective as the current three-drug regimen of adriamycin, bleomycin and vincristine (ABV) but that DaunoXomeb therapy reduced the incidence of side effects that can adversely affect a patient's quality of life. In addition, review of the Company's phase III data led the FDA to conclude that DaunoXomeb therapy reduces the cardiotoxicity normally associated with anthracycline-based chemotherapy. NeXstar presented data from its phase III clinical trial at the FDA's Oncologic Drugs Advisory Committee. The Company's phase III trial 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 DaunoXomeb and a three-drug regimen of adriamycin, bleomycin and vincristine (ABV). Based on its review, the Advisory Committee recommended that DaunoXomeb should be approved as a first-line therapy. "The FDA's approval of DaunoXomeb as a primary therapy for advanced Kaposi's sarcoma represents an important advance in the treatment of this debilitating and often life-threatening disease," said Michael E. Ross, M.D., NeXstar's Vice President for Medical and Regulatory Affairs. "We are proud that we can now offer DaunoXomeb as an important option as the initial therapy for controlling advanced Kaposi's sarcoma in HIV-positive patients." "This approval, NeXstar's first in the United States, following on the heels of DaunoXomeb's recent European approvals, puts us in the enviable position of launching a new drug simultaneously in both the U.S. and Europe," said Patrick J. Mahaffy, NeXstar's President and Chief Executive Officer. "By positioning the price of DaunoXomeb at half that of a competing liposomal product and equivalent to the current combination therapy, we believe we are demonstrating that it is possible to create novel, effective and safer drugs that are also cost-effective. This is a tremendous marketing opportunity for our Company and one that we are going to go after aggressively. Our sales force is already in place and trained, and we expect to hit the ground running." 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 currently markets two drugs, AmBisome and DaunoXomeb. The Company has headquarters in Boulder, Colorado; research, development and manufacturing facilities in San Dimas, California; Antwerp, Belgium; Lakewood, Colorado, and Boulder; and marketing subsidiaries worldwide.
|
