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May 9, 2016 – U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATETM-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 (sNDA), 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).
Adding ibrutinib to other therapies such as bendamustine/rituximab (BR) improves outcomes and ibrutinib is clearly superior to chlorambucil as a single therapy showing an overall survival advantage, Now this information is an official part of the prescribing information.
Brian Koffman, MD
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