Additional indication for Janssen's Imbruvica approved in EU

The European Commission has approved US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag’s Imbruvica (ibrutinib) capsules as a treatment option for adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

This approval represents a significant step forward for patients suffering from WM, the company said. There were previously no treatment options approved across Europe for this rare and slow-growing type of blood cancer. The US Food and Drug Administration expanded the use of Imbruvica to that of WM treatment early this year (The Pharma Letter January 30).

Ibrutinib is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics, an AbbVie (NYSE: ABBV) subsidiary. Janssen affiliates market ibrutinib in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except the USA, where Janssen Biotech and Pharmacyclics co-market it.