FDA Updates Ibrutinib Labeling to Include Survival Data

The U.S. Food and Drug Administration (FDA) expanded the prescribing information for ibrutinib to include overall survival results from two phase III RESONATE-2 trials of patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). After a median follow-up of 28.1 months, patients treated with ibrutinib demonstrated a statistically significant reduction in the risk of death (hazard ratio = 0.44; 95% CI 0.21-0.92).

The update also includes safety and efficacy data from the phase III HELIOS trial assessing the use of ibrutinib plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed/refractory CLL/SLL patients. The data demonstrate an improvement in progression-free survival and overall response rate with ibrutinib plus BR compared with placebo plus BR.

The FDA has also approved a new indication for ibrutinib to include the treatment of patients with SLL with or without the del17p.

Source: AbbVie press release, May 9, 2016.