Janssen has announced the European Commission (EC) approval of Imbruvica (ibrutinib) for expanded use in two indications.
The regulator has approved expanding the scope of the drug to include its use in combination with obinutuzumab in adults with previously untreated chronic lymphocytic leukaemia (CLL), and for the treatment of adults with Waldenström's macroglobulinemia (WM) in combination with rituximab.
The approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019, and marks the fifth European approval in as many years.
The approvals were based on the Phase II iLLUMINATE (PCYC-1130) study and the Phase III iNNOVATE (PCYC-1127) study, respectively.
“The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively,” said Dr Alessandra Tedeschi, medical director, department of Hematology, Niguarda Hospital, and investigator in both studies.
She continued, “These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers.”
CLL is typically a slow-growing blood cancer of the white blood cells. The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.
WM is a rare form of non-Hodgkin’s lymphoma that causes overproduction of a protein called monoclonal immunoglobulin M antibody, which causes a thickening of the blood.