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Phase III follow up data on Imbruvica (ibrutinib) shows efficacy in chronic lymphocytic leukemia and small lymphocytic lymphoma- AbbVie

Read time: 1 mins
Last updated:7th Jun 2016
Published:7th Jun 2016
Source: Pharmawand

AbbVie has announced longer-term follow-up results from Phase III studies of Imbruvica (ibrutinib) in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL). Findings include an analysis of outcomes from the RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115) trials, which showed Imbruvica was associated with favorable progression-free survival (PFS) and overall survival (OS) regardless of line of therapy (previously treated or treatment-na�ve; abstract 7520).

An analysis of the RESONATE and RESONATE-2 trials showed Imbruvica was associated with favorable PFS and OS outcomes, as well as a high overall response rate (ORR) in previously treated and treatment-na�ve patients with CLL/SLL, regardless of line of therapy. The median PFS and OS were not reached in treatment-na�ve or previously-treated patients; 89-92% of patients treated with ibrutinib at first or second line of therapy remained progression-free at two years. Additionally, ORR was high in both previously treated and treatment-na�ve patients (92% and 91%, respectively).

The safety profile was similar for both patient groups1 and was consistent with previously-reported outcomes. Data from the RESONATE and RESONATE-2 studies served as the basis for the 2014 and 2016 FDA approvals of Imbruvica for patients with CLL/SLL. The most commonly occurring adverse reactions (more than 20%) in studies that supported the FDA approvals for patients with CLL/SLL were neutropenia, thrombocytopenia, anemia, diarrhea, musculoskeletal pain, nausea, rash, bruising, fatigue, pyrexia and hemorrhage.

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