Imbruvica (ibrutinib) is now approved in all 28 member states to treat Waldenstrom’s macroglobulinemia (WM).
WM is a rare, slow-growing blood cancer.
Imbruvica was approved for treatment of WM in the US earlier this year.
Imbruvica, which became the first and only treatment for WM earlier this year in the US, is now available in the EU for patients with WM who have received at least one prior therapy or for patients who are unsuitable for chemotherapy.
In a phase II multicenter study, 63 patients with WM, who had received a median of two prior therapies, received Imbruvica 420 mg once daily. After a median followup period of 19 months, there was a 91% overall response rate in Imbruvica-treated patients in terms of any amount of tumor shrinkage.
Imbruvica already is approved in the EU for treatment of refractory multiple cell lymphoma and chronic lymphocytic leukemia.