31 May 2016 - Imbruvica is now indicated across all lines of chronic lymphocytic leukaemia in the European Union.
AbbVie today announced that the European Commission (EC) approved Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukaemia (CLL), expanding upon the initial EC approval in October 2014 for certain patients with CLL. This decision comes just one month after the CHMP of the EMA issued an opinion in favor of the use of Imbruvica for the treatment of adult patients with first-line CLL in the European Union (EU).
This approval marks a number of significant landmarks for Imbruvica: this is the drug's fifth treatment indication in the EU and this approval means that Imbruvica is now available to treat all lines of CLL in the EU. Patients with treatment-naive CLL, relapsed/refractory CLL and those with the genetic mutations del 17p or TP53, can all now benefit from treatment with single-agent Imbruvica.
For more details, go to: https://news.abbvie.com/news/european-commission-approves-imbruvica-ibrutinib-for-first-line-treatment-patients-with-chronic-lymphocytic-leukemia.htm