AbbVie, a worldwide biopharmaceutical company, recently announced that officials at the European Commission (EC) have approved Imbruvica to be used as a first-line treatment option for chronic lymphocytic leukemia (CLL).
This approval applies specifically to adult patients. With this approval, Imbruvica can now be used for all lines of CLL cases found within the European Union (EU).
The EC approved this treatment after the EU's Committee for Medicinal Products for Human Use (CHMP) recommended that Imbruvica receive approval. In October 2014, the EC first granted approval for certain patients; in April 2016, CHMP recommended the approval; now, the leaders have granted their final approval for the treatment option.
The EC based its approval decision on information that was gathered from the phase-three Resonate-2 (PSYC-1115) trial. This trial was also the basis for the U.S. approval of the CLL/SLL treatment in March 2016 and May 2016.
The trial showed significant improvements for CLL patients, including those with relapsed/refractor CLL, treatment-naïve CLL and genetic mutations in del 17p or TP53.
AbbVie has achieved several landmarks with the new Imbruvica treatment, which has gained its fifth indication within the U.S. This means that the drug can be easily accessed to treat a variety of CLL-related cases.
