AbbVie Gets Europe's Approval For Its IMBRUVICA For Chronic Lymphocytic Leukemia Treatment

AbbVie ABBV revealed Tuesday that the European Commission (EC) has given its approval for its IMBRUVICA (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL). According to the company, the approval expanded the initial EC approval given in October 2014 for some patients with CLL. AbbVie said that the latest decision comes a month after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued an opinion in favor of the use of IMBRUVICA for the treatment of adult patients with first-line chronic lymphocytic leukemia (CLL) in the European Union (EU). The company added that the broadened indication was based on data from the Phase 3 RESONATE-2 (PCYC-1115) trial. Incidentally, it provided as the basis for the March 2016 approval in the first-line CLL/SLL treatment setting, as well as, the May 2016 update to the United States. The drug maker's statement said, "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." AbbVie said that IMBRUVICA was jointly developed, as well as, commercialized in the U.S. by Pharmacyclics LLC, an AbbVie firm and Janssen Biotech, Inc. As far as the Europe is concerned, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market IMBRUVICA in EMEA (Europe, Middle East, Africa), and the rest of the world. The company indicated that IMBRUVICA was already approved in Europe to treat adult patients with relapsed/refractory mantle cell lymphoma (MCL), adult patients with CLL who have received at least one prior therapy or who have del 17p or TP53 mutations, and adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or as a first-line treatment for WM patients unsuitable for chemo-immunotherapy. On Friday, the stock closed 1.28 percent higher.