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Ofatumumab Recommended for Approval in Double-Refractory Chronic Lymphocytic Leukemia
Ofatumumab Recommended for Approval in Double-Refractory Chronic Lymphocytic Leukemia
MJM Dales
20090431
2009 May 31
Elsevier Global Medical News
Ofatumumab Recommended for Approval in Double-Refractory Chronic Lymphocytic Leukemia
Elsevier Global Medical News. 2009 May 31, MJM Dales
ORLANDO (EGMN)-Ofatumumab got the nod from an advisory panel to the Food and Drug Administration for use as a single agent in the treatment of patients with B-cell chronic lymphocytic leukemia that has failed to respond to both fludarabine and alemtuzumab, so-called double-refractory disease. The Oncologic Drugs Advisory Committee, by a vote of 10 for and 3 against, found that a 42% objective response rate (99% CI=26%-60%) and a median duration of response of 6.5 months (99% CI=5.8-8.3 months) in...