The European Commission granted marketing approval for Imbruvica (ibrutinib) throughout the European Union, for relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukemia patients who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.
Imbruvica, a first-in-class, oral, once-daily, non-chemotherapy treatment, is being jointly developed and commercialized in the U.S. by Pharmacyclics Inc. and Janssen Biotech Inc., which will market Imbruvica in Europe.
The approval was based on data from a phase II study in MCL, the phase III RESONATE study in CLL and small lymphocytic lymphoma and the phase Ib/II study in CLL/SLL. A worldwide regulatory filing program for ibrutinib currently is underway, according to the drug’s sponsor.
Imbruvica is approved in the U.S. for three indications: for the treatment of patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment-naive and previously treated del 17p CLL patients.
Pharmacyclics also entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of Imbruvica in combination with Gazyva (obinutuzumab), a CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.
Initially, a phase III study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. Gazyva is a registered trademark of Genentech Inc.
The study of the investigational combination of Imbruvica and Gazyva through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.
Janssen Research & Development also submitted a supplemental New Drug Application for Imbruvica to FDA for the treatment of patients with Waldenstrom’s macroglobulinemia. If approved, this will become the fourth indication for Imbruvica, which received an FDA Breakthrough Therapy Designation for WM in February 2013.
