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FDA Approves Rituximab in Combination with Other Therapies for Untreated CLL |
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Wednesday, 10 March 2010 17:05 |
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The FDA recently announced approval for the monoclonal antibody rituximab in combination with fludarabine and cyclophosphamide for patients with previously untreated chronic lymphocytic leukemia (CLL) and patients with CLL who have failed on previous therapies.
The FDA based its approval of rituximab on progression-free survival (PFS) results from two phase-3 studies, CLL8 and REACH, which compared rituximab plus fludarabine and cyclophosphamide with fludarabine and cyclophosphamide alone. Results indicated that patients assigned treatment with rituximab had a 32% improvement in PFS compared with those on fludarabine and cyclophosphamide alone.
To assist in the prediction of a patient's response to rituximab, MPLN offers flow cytometry to evaluate CD20 protein expression in individuals with CLL. For more information about this test or other companion diagnostic tests offered by MPLN, contact a technical service specialist at 800-932-2943. |