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Rituximab Plus Chemotherapy Approved in Canada for Previously Untreated CLL
NEW YORK -- August 17, 2009 -- Health Canada has approved rituximab (Rituxan) in combination with fludarabine and cyclophosphamide (FC chemotherapy) for use in patients with previously-untreated chronic B-cell lymphocytic leukemia (CLL) stage B or C.
The approval is based on results from the phase 3 international, multicentre, randomised study, CLL8.
The study included 817 patients with CLL receiving first-line treatment. Patients received either rituximab in combination with FC chemotherapy or chemotherapy alone. The primary endpoint of the study was progression-free survival.
Results showed that patients receiving rituximab in combination with FC chemotherapy as first-line treatment lived an average of 40 months without their cancer progressing compared with an average of 32 months for patients receiving FC chemotherapy alone.
No new or unexpected safety signals were observed.
SOURCE: Edelman Group
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