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The Cancer Letter Inc.
PO Box 9905
DC 20016
Tel: 202-362-1809
Fax: 202-379-1787
publication date: May 13, 2016
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Drugs and Targets

FDA Expands Imbruvica Label To Include CLL and SLL Patients 


FDA approved an expansion to the Imbruvica (ibrutinib) prescribing information based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

The approved label now includes overall survival data from the Phase III RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. The updated label also contains clinical data from the phase III HELIOS (CLL3001) trial investigating the use of Imbruvica in combination with bendamustine and rituximab versus placebo plus BR in patients with relapsed or refractory CLL/SLL.

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