Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Commission (EC) has approved Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL).
Subscribe to our email newsletter
It expands the initial EC approval in October 2014 for several patients with CLL. Imbruvica is now available to treat all lines of CLL in the European Union (EU).
The approval was based on data from the Phase 3, randomized, open-label RESONATE-2 trial, which saw the enrollment of 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older in the US, EU and other regions.
After a median of 18 months of follow-up, Imbruvica was associated with a significant improvement in several efficacy endpoints versus chlorambucil in patients aged 65 or older with newly diagnosed CLL.
It was associated with a 90% progression-free survival rate versus 52% for chlorambucil. Imbruvica demonstarted statistically significant prolonged overall survival.
The safety of Imbruvica in the treatment-naïve CLL patient population was consistent with earlier reported studies.
Patients with treatment-naive CLL, relapsed/refractory CLL and those with the genetic mutations del 17p or TP53, can now benefit from treatment with single-agent Imbruvica.
Imbruvica is jointly developed and commercialized in the US by AbbVie company Pharmacyclics and Janssen Biotech.
Janssen-Cilag International holds the marketing authorization in Europe and its affiliates market the drug in Europe, Middle East, Africa, and the rest of the world.