Posted by Michael Wonder on 10 May 2016
U.S. FDA expands Imbruvica (ibrutinib) label to include overall survival data in previously untreated chronic lymphocytic leukaemia and new indication for small lymphocytic lymphoma patients
9 May 2016 - AbbVie today announced the U.S. FDA updated the Imbruvica (ibrutinib) Prescribing Information to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATE-2 (PCYC-1115) trial.
The Imbruvica label has also been updated with safety and efficacy data from the Phase 3 HELIOS (CLL3001) trial assessing the use of Imbruvica in combination with bendamustine and rituximab (BR) versus placebo plus BR in relapsed/refractory patients with CLL/SLL. As well, following a review of the November 2015 supplemental new drug application, the FDA has approved a new Imbruvica indication to include the treatment of patients with SLL with or without the deletion of chromosome 17p (del 17p).
Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company, and Janssen Biotech, Inc.
