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AbbVie announced that the Food and Drug Administration (FDA) has updated the labeling for Imbruvica (ibrutinib Pharmacyclics and Janssen Biotech) to include new data from two Phase 3 studies supporting its use in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL).
The Imbruvica labeling now contains overall survival (OS) results from the randomized, multicenter, open-label, Phase 3 RESONATE-2 (PCYC-1115; n=269) trial that evaluated previously-untreated CLL/SLL patients. Data from this trial helped support the recent FDA approval of Imbruvica as first-line treatment for CLL patients. The supplemental OS analysis, which included 41% of patients in the chlorambucil arm who crossed over to receive Imbruvica, demonstrated a statistically significant 56% reduction in the risk of death after a median follow-up of 28.1 months (HR 0.44, 95% CI: 0.21, 0.92).
The labeling has also been updated with efficacy and safety data from the randomized, multicenter, double-blind, Phase 3 HELIOS (CLL3001; n=578) trial that evaluated Imbruvica in combination with bendamustine and rituximab (BR) vs. placebo plus BR in relapsed/refractory patients with CLL/SLL. Imbruvica plus BR demonstrated an 80% reduction in the risk of progression or death (HR 0.20, 95% CI: 0.15, 0.28) vs. placebo plus BR. This data is the first to show an improvement in progression-free survival (PFS) and overall response rate (ORR) with Imbruvica when combined with BR vs. placebo plus BR in patients with relapsed/refractory CLL/SLL.
In addition, the FDA has approved the use of Imbruvica for the treatment of patients with SLL with or without the deletion of chromosome 17p (del 17p) based on the November 2015 supplemental New Drug Application (sNDA) review.
Imbruvica, a Bruton’s tyrosine kinase (BTK) inhibitor, is already indicated to treat patients with CLL/SLL, patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and patients with Waldenström’s macroglobulinemia.
For more information call (877) 877-3536 or visit Imbruvica.com.
