Janssen's Imbruvica has been approved in Europe for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL), thus expanding its scope to include all adults with the condition.
The new approval is based on the findings of the Phase III, randomised, open-label RESONATE-2 trial, published in The New England Journal of Medicine last year, which showed that Imbruvica (ibrutinib) significantly prolonged overall survival; 98 percent of patients were still alive after two years compared to 85 percent if those in the chlorambucil arm.
Safety in the treatment-naïve CLL patient population was consistent with previously reported studies, with the most common adverse reactions reported being 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. "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."
Imbruvica is now cleared in the region to treat: adult patients with relapsed or refractory mantle cell lymphoma; previously untreated adult patients with CLL or those who have received at least one prior therapy; in adults with Waldenström's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.