Credit: CDC
The US Food and Drug Administration (FDA) has granted approval for ibrutinib (Imbruvica) as the first and only treatment for patients with Waldenstrom’s macroglobulinemia (WM).
The drug is now approved as a single agent for use in all lines of therapy.
This is the fourth indication for ibrutinib, which is also FDA-approved to treat patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, CLL patients with del 17p, and patients with mantle cell lymphoma.
Ibrutinib is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.
The latest FDA approval is based on results from a multicenter, phase 2 study in which researchers evaluated the efficacy and tolerability of ibrutinib in 63 patients with previously treated WM.
The response rate, according to an independent review committee, was 62%. Eleven percent of patients had a very good partial response rate, and 51% had a partial response rate.
The median duration of response has not been reached, with a range of 2.8 to 18.8 months.
The most commonly occurring adverse events (>20%) were neutropenia, thrombocytopenia, diarrhea, rash, nausea, muscle spasms, and fatigue.
Six percent of patients discontinued treatment due to adverse events. Events leading to dose reduction occurred in 11% of patients.
For more details, see the full prescribing information.
