The drug Nipent (pentostatin) was approved Nov. 11, 1991, for treating patients seriously ill with hairy cell leukemia who do not respond to conventional treatment with alpha interferon.
The drug had in August 1988 been granted treatment IND status (which allowed it to be released to desperately ill patients before complete information on safety and effectiveness was available) and was being distributed through the National Cancer Institute s cancer treatment centers throughout the United States. In July of 1991, an FDA advisory committee evaluated data from the clinical trials and recommended Nipent's approval.
Hairy cell leukemia primarily affects adults, but is also seen in some children. It is associated with anemia, bone marrow suppression, enlargement of the spleen, and infection. The disease, which is life-threatening and difficult to treat, affects about 2,500 patients in the United States, with about 500 to 600 new patients being diagnosed each year.
Nipent is a derivative of the fungal organism Streptomyces antibioticus, the microorganism from which many antibiotics, including tetracycline, are derived. It is manufactured by the Warner-lambert Company, Ann Arbor, Mich.
COPYRIGHT 1992 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
Contact
Home
A
Hairy cell leukemia