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.