- The EMA's Committee for Medicinal Products for Human Use (CHMP) adopt a positive opinion supporting approval of Imbruvica (ibrutinib) as a treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) or adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or as a first-line treatment in patients with the 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.
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Ibrutinib is being co-developed by Johnson & Johnson (JNJ -0.2%) unit Janssen-Cilag International NV and Pharmacyclics Switzerland GmbH. Once approved, Janssen will market it exclusively in EMEA (Europe, Middle East, Africa) and co-promote it in the U.S.
- A final decision from the European Commission usually takes ~3 months.