publication date: May. 13, 2016

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.

Updated data from the RESONATE-2 trial reflect a statistically significant 56 percent reduction in the risk of death with Imbruvica compared to chlorambucil after a median follow-up of 28.1 months (HR=0.44 [95% CI, 0.21, 0.92]). The RESONATE-2 trial served as the basis for the March 2016 FDA approval of Imbruvica as a first-line treatment for patients with CLL.

Additionally, the first data from the HELIOS study on the use of Imbruvica in combination with other therapies were added to the label, highlighting the improvement in progression-free survival and overall response rate when using Imbruvica plus BR versus placebo plus BR in patients with relapsed/refractory CLL/SLL. Following a review of the November 2015 supplemental New Drug Application, the FDA has expanded the indication to include the use of Imbruvica for SLL patients with or without deletion of the chromosome 17p.

“The update helps to affirm the established efficacy, safety and tolerability of this therapy for the … Continue reading 42-19 FDA Expands Imbruvica Label To Include CLL and SLL Patients

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