AbbVie announced, the 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).
The RESONATE-2 trial served as the basis for the March 2016 FDA approval of IMBRUVICA for the first-line treatment of CLL patients. Notably, the OS data now included in the IMBRUVICA PI provide a longer-term update to results published in The New England Journal of Medicine, with a median follow-up of 28.1 months. The label updates based on HELIOS represent the first-ever data demonstrating an improvement in progression-free survival (PFS) and overall response rate (ORR) with IMBRUVICA when combined with BR versus placebo plus BR in patients with relapsed/refractory CLL/SLL.
"This update helps to affirm the established efficacy, safety and tolerability of this therapy for treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents," said Jan Burger, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine,
"We believe the IMBRUVICA label is very strong for the treatment of certain hematologic malignancies and is now reinforced not only by data evaluating its use as a single agent, but also in combination with other commonly used chemotherapy regimens." said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics.
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