The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Imbruvica® (ibrutinib) in two indications.
One recommendation is for the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The second is for use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
The Positive Opinion for CLL was based on results from the Phase 3 iLLUMINATE (PCYC1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.
After a median follow-up of 31.3 months, median progression-free survival (PFS) was significantly longer in the ibrutinib plus obinutuzumab group than in the chlorambucil plus obinutuzumab group.
In WM, the Positive Opinion was supported by data from the Phase 3 iNNOVATE (PCYC-1127) study, presented at the 60th Annual Meeting of the American Society of Hematology (ASH) in December 2018. The study evaluated the safety and efficacy of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.
At a median follow up of 30.4 months, a significant improvement in the Independent Review Committee (IRC)-assessed primary endpoint of PFS was seen with ibrutinib plus rituximab when compared with placebo plus rituximab.
Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies, said: “This is an important step forward in further enhancing our ability as haematologists to meet the treatment needs of more patients with these complex blood cancers. Ibrutinib has already offered important progress in both CLL and WM in the indications for which it is currently approved, and these new combination regimens show the potential to further extend the remission period for patients versus standard of care.”
Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France, said: “We are incredibly encouraged by these CHMP recommendations, which represent our continued commitment to develop chemotherapy-free combinations for those living with CLL and WM.
“Ibrutinib has been used to treat more than 140,000 patients worldwide and we are continuing to deliver on our ambition to optimise outcomes for patients with complex B-cell malignancies, that have in the past been very difficult to treat.”
Both Positive Opinions will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.
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.
Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).