Genzyme Launches Key Test to Monitor Gleevec® Resistance

Genzyme Corporation has announced the availability of a test to monitor drug resistance in chronic myeloid leukemia (CML) patients who are treated with Gleevec^® (imatinib mesylate).

Despite high response rates to Gleevec, approximately four to five percent of patients who were initially treated will develop resistance during therapy.

Genzyme's BCR-ABL Mutation Analysis test will assist physicians in evaluating resistance to therapy and facilitate appropriate adjustments to treatment.

The molecular hallmark of CML is a mutation known as BCR-ABL. This mutation is the specific target for Gleevec and is found in 95 percent of patients with CML.

In relapse patients, the majority of secondary mutations in the ABL portion of the gene correlate with treatment failure. Genzyme's test is designed to detect all secondary BCR-ABL mutations and therefore predicts resistance to Gleevec.

"This is a very exciting time for leukemia patients and their caregivers because this test will provide them with more information about their disease and will give them the ability to personalize their treatment," said Mara Aspinall, president of Genzyme Genetics, the business unit of Genzyme Corp.

"We are pleased to offer another important predictive test that can play a critical role in the way oncologists and patients manage their cancer," she added.

Gleevec was approved by the U.S. Food and Drug Administration in May, 2001 as the first drug in a new class of molecular targeted therapies for CML.

In October, Genzyme announced that it entered into a license agreement with UCLA to obtain exclusive, worldwide diagnostic rights to UCLA's discovery of gene mutations believed to be associated with drug resistance to Gleevec.