Posted by Michael Wonder on 21 Nov 2018
Janssen seeks expanded use of Imbruvica (ibrutinib) in two indications in Europe
14 November 2018 - Applications submitted to the EMA for new combinations in adult patients with chronic lymphocytic leukaemia and Waldenström's macroglobulinaemia.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two Type II variation applications to the EMA seeking approval for the expanded use of Imbruvica (ibrutinib). One application seeks to include use of ibrutinib in combination with obinutuzumab in previously untreated adults with chronic lymphocytic leukaemia and to add long-term follow-up data from the existing label studies RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115).
The second is for use of ibrutinib plus rituximab for the treatment of previously untreated and relapsed/refractory adults with Waldenström's macroglobulinemia.
