The Food and Drug Administration announced Monday that ithas approved Berlex Laboratories Inc.'s fludarabine phosphateto treat chronic lymphocytic leukemia (CLL) patients who havenot responded to standard therapies.

Fludarabine phosphate, trade named Fludara, is a cell-reducingagent that inhibits DNA synthesis in leukemic cells. It wasgranted orphan drug status in 1988.

Berlex will market Fludara through its Berlex Laboratories,Alameda unit (formerly Triton Biosciences Inc.) in California,which has an exclusive license from the U.S. government.

Fludara will become commercially available "in the next fewmonths," said Berlex spokesman David Ringler. The companysaid it had not yet priced Fludara, which will be administeredin 50mg. doses on five consecutive days each month.

The market includes virtually all CLL patients. While most CLLpatients respond well initially to conventional drugs, over timealmost all treatments lose their effectiveness.

"About 50,000 Americans have CLL, and 8,000 new cases arereported each year," said Marianna Jordan, a spokeswoman forthe Leukemia Society of America. "I would say that just aboutany patient would be a candidate for fludarabine."

Dr. Michael Keating, a researcher at the M.D. Anderson CancerCenter in Houston who directed one of the two clinical trials onthe drug, said that "the whole CLL community are potentialusers of fludarabine. The present indication is patients whohave had previous therapy. Eventually, it will be used as afirst-line regime for the disease, perhaps combined withexisting therapies."

The National Cancer Institute (NCI) is conducting three-waytrials on previously untreated CLL patients, comparing theeffects of fludarabine, chlorambucil (the most commonly usedCLL drug), and a combination of fludarabine and chlorambucil.

The Scripps Clinic and Research Center in La Jolla, Calif., istesting another CLL drug, 2-chlorodeoxyadenosine (2-CdA).Both 2-CdA and fludarabine are nucleoside analogs that act toblock DNA synthesis.

Dr. Ernest Beutler of Scripps told BioWorld that 2-CdA is inPhase II trials for a variety of disorders, including CLL, hairy-cell lymphoma, non-Hodgkins lymphoma, Hodgkins disease andsome autoimmune diseases.

Fludarabine was first synthesized at the Southern ResearchInstitute in Birmingham, Ala., with NCI financial support.

-- Steve Usdin Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.

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