The first drug resulting from the Johnson & Johnson researchagreement with The Scripps Research Institute was approvedby the FDA earlier this month.
Leustatin, a nucleoside for treating hairy cell leukemia, is beingintroduced by Ortho Biotech, a subsidiary of Johnson & Johnson.Scripps will receive royalties from Johnson & Johnson.
About 3,000 patients have the disease, which primarily affectsmen over age 50. There are about 600 new cases each year.Named for the altered appearance of white blood cells, thismalignancy is rare, but often fatal. It represents about 2percent of all leukemia cases.
Treatments with nucleosides such as Leustatin (2-chlorodeoxyadenosine) have greatly increased the percentageof durable complete remissions. Clinical studies prior to thenew drug application showed that one-half to nearly two-thirds of patients responded completely after only one courseof therapy.
Prior to FDA clearance, Leustatin had been available free ofcharge through the National Cancer Institute under a Group Ctreatment protocol.
The manufacturer's cost to distributors for one course of sevendays infusion will be $2,085 to $2,800 for 70 mg, depending onthe purchasing agent, which is less than other typical regimensfor the disease. Ortho Biotech has established a compassionatecare program.
The drug inhibits both DNA synthesis and repair, so it iseffective in slower-growing cancers such as hairy cell leukemia,in which up to 90 percent of the malignant cells may not bedividing.
Leustatin is the first oncology drug introduced by OrthoBiotech, which also markets the recombinant humanerythropoietin Procrit, and a monoclonal antibody for thereversal of acute kidney transplant rejection.
-- Nancy Garcia Associate Editor
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