EC OKs New Use for AbbVie’s Cancer Drug ImbruvicaBy
The European Commission (EC) has approved AbbVie’s Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL), expanding upon the initial EC approval in October 2014 for certain patients with CLL.
This decision comes just one month after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued an opinion in favor of the use of Imbruvica for the treatment of adult patients with first-line CLL in the European Union.
Imbruvica is an oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK), a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. Imbruvia blocks signals that tell malignant B cells to multiply and spread uncontrollably.
AbbVie acquired Imbruvcia in its $21 billion acquisition of Pharmacyclics in 2015
Imbruvica is approved in the US to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and patients with WaldenstrÃ¶m’s macroglobulinemia (WM). It is approved in the EU to treat adult patients with relapsed or refractory MCL, previously untreated adult patients with chronic lymphocytic leukaemia (CLL), or those who have received at least one prior therapy, and adult patients with WM who have received at least one prior therapy, or first line patients unsuitable for chemo-immunotherapy
Imbruvica is being studied alone and in combination with other treatments in several blood and solid tumor cancers.