J&J Unit Seeks Expanded Imbruvica Indication from EMA

Janssen-Cilag International, the European unit of Johnson & Johnson subsidiary Janssen Pharmaceutical Companies, is asking the European Medicines Agency to broaden the label of Imbruvica for treatment-naïve patients with chronic lymphocytic leukemia.

The filing is based on a Phase 3 trial that compared Imbruvica (ibrutinib) — which is currently approved in Europe for treatment of adult patients with relapsed or refractory mantle cell lymphoma — with chlorambucil in patients aged 65 and older with treatment-naïve CLL or small lymphocytic lymphoma.

Imbruvica demonstrated superiority over chlorambucil in progression-free survival, as well as secondary efficacy endpoints, including overall survival, overall response rate and hematologic function.

Janssen also submitted an sNDA to the FDA in September based on these data for the same treatment population. Imbruvica was developed by Cilag GmbH International and Pharmacyclics, an AbbVie company.