It was announced today that the European Commission (EC) has approved ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

This follows its positive opinion from the European Medicines Agency earlier this month.

Ibrutinib is now approved for all patients with CLL, expanding the number of patients who may benefit from this treatment.

The expanded ibrutinib indication is based on data from the Phase 3, randomised, open-label RESONATETM-2 trial, as published in New England Journal of Medicine (NEJM) in 2015.

“Ibrutinib has shown remarkable improvements in overall survival, progression-free survival and response rates compared with chlorambucil,” said Professor Paolo Ghia, Associate Professor of Internal Medicine at Università Vita-Salute San Raffaele in Milan, Italy. "The RESONATETM-2 data indicate that ibrutinib can provide a much-needed first line treatment alternative for many patients.”

Despite the availability of effective first line chemo-immunotherapy regimens for CLL, many patients, especially the elderly, cannot tolerate their adverse effects.

CLL is generally a slow-growing blood cancer of the white blood cells, and is predominantly a disease of the elderly, with a median age of 72 at diagnosis.

The prevalence rate of CLL in Europe among men and women is approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.

Results from the RESONATETM-2 study showed that ibrutinib significantly prolonged overall survival (OS) (HR=0.16, 95 percent CI 0.05 to 0.56; P=0.001), with 98 percent of patients still alive after two years, compared to 85 percent for patients randomised to the chlorambucil arm.

The median progression-free survival (PFS) was not reached for patients receiving ibrutinib versus 18.9 months for those in the chlorambucil arm, representing a statistically significant 84 percent reduction in the risk of death or progression in the ibrutinib arm (HR=0.16, 95 percent CI 0.09 to 0.28; P<0.001).

The overall safety of ibrutinib in the treatment-naïve CLL patient population was consistent with previously reported studies.

The most common adverse reactions (ARs) (≥20 percent) of any Grade in the RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30 percent), cough (22 percent) and nausea (22 percent).

“The availability of a targeted therapy as an initial treatment is a tremendous step forward for people affected by CLL and has been long-awaited by the CLL community,” said Nick York, patient advocate, CLL Advocates Network (CLLAN). “Many patients are considered unsuitable for the current first line standard of care so there is a real need for new, effective treatment options for these patients.”

Source: European Medicines Agency