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May 31, 2016 – Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). This broadens the indication beyond the initial CLL approval by the EC in October 2014. 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 RESONATE™-2 trial, as published in The 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 RESONATE™-2 data indicate that ibrutinib can provide a much-needed first line treatment alternative for many patients.”
“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.”
This latest EC approval follows the decision by the U.S. Food and Drug Administration on 04 March 2016 to approve the expanded use of ibrutinib capsules for treatment-naïve patients with CLL.
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