Ibrutinib and Idelalisib Coming to Europe Soon

Zosia Chustecka


July 25, 2014

Two novel targeted agents that look to change the whole paradigm of treatment for chronic lymphocytic leukemia (CLL) look like they will be available in Europe soon.

Ibrutinib (Imbruvica, Janssen) and idelalisib (Zydelig, Gilead) have both been recommended for approval by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) at its July meeting.

Both drugs are recommended for use in treatment of adult patients with CLL who have received at least 1 prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemoimmunotherapy.

They are also both recommended for use in certain lymphomas, although the indication is different for each drug.

Ibrutinib is also recommended for use in the treatment of adult patients with mantle cell lymphoma that has relapsed after previous treatments or is not responding to other treatments. Ibrutinib has orphan drug designation for this indication; mantle cell lymphoma is a very rare cancer, affecting around 15,000 people in the European Union. There is no standard-of-care treatment for this cancer when it relapses and is not responding to previous treatments, the EMA notes.

Idelalisib is also recommended for use for adult patients with follicular lymphoma that has not responded to 2 previous treatments.

The indications are similar to those in the United States, where ibrutinib was approved for CLL in February and for use in mantle cell lymphoma in November 2013, and idelalisib was approved for both CLL and lymphoma just a few days ago.

Both drugs have generated considered excitement among experts who treat hematological malignancies, and there is hope that these oral targeted agents will eventually replace chemotherapy for the treatment of CLL. Although they are at present being used in patients who have progressed after chemotherapy (i.e., as second-line), their efficacy and tolerability have so impressed clinicians involved in their clinical trials that there is great enthusiasm to try these agents as front-line therapy, and those trials are now underway.

The EMA commented that ibrutinib and idelalisib "have the potential to bring new treatment options for patients suffering from these rare cancers, especially in cases where previous treatments have stopped working, as they act in different ways to previously authorized medicines."

Ibrutinib acts through a novel mechanism against the abnormal B-cells by blocking the action of an enzyme known as Bruton's tyrosine kinase, which is important for the growth, migration, and survival of B-cells. Idelalisib blocks the effects of another enzyme called PI3K-delta, which plays a role in the growth, migration, and survival of white blood cells.

The EMA also notes that today's announcement is "an intermediary step" on the drug's path to patient access. The CHMP recommendation will now be sent to the European Commission for the adoption of a decision on European Union–wide marketing authorizations. Once marketing authorizations have been granted, decisions about price and reimbursement will then take place at the level of each European Union member state considering the potential role/use of these medicines in the context of the national health system of that country.


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