The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding 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 (CLL) and to add long-term follow-up data from the existing label studies RESONATETM (PCYC-1112) and RESONATETM-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 (WM).
Janssen-Cilag Europe, Middle East and Africa (EMEA) haematology therapy area lead Catherine Taylor said: “Today’s news brings us one step closer to potentially offering ibrutinib in new combinations for patients where unmet needs still persist.
“Ibrutinib continues to demonstrate clinical benefit over the long term for a broad group of patients living with blood cancer, and we look forward to working with relevant authorities to secure approval of these new combinations.”
Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.
The CLL submission is supported by positive results from the Phase 3 iLLUMINATE (PCYC-1130) study which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.
Study findings from iLLUMINATE will also be featured as an oral presentation (abstract #691), whilst further analysis of RESONATETM and RESONATETM-2 results in comparison with real-world evidence databases (abstract #4427) will be included at the American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in San Diego next month.
A supplemental New Drug Application (sNDA) which was also recently submitted to the U.S. Food and Drug Administration (FDA) received Priority Review.
In WM, the submission is supported by data from the Phase 3 iNNOVATE (PCYC-1127) study evaluating ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.
Follow-up efficacy and safety findings from the iNNOVATE study will also be presented at ASH 2018 (abstract #149).4 In August 2018, the FDA approved ibrutinib in combination with rituximab for the treatment of WM based on the data from iNNOVATE.
Source: Company Press Release