The drug ibrutinib (trade name: Imbruvica) has been approved in Germany since July 2015 for the treatment of Waldenström's macroglobulinemia in adults.
Waldenström's macroglobulinemia is a very rare type of cancer in which B cells multiply uncontrollably in the blood. These mutated cells of the immune system also produce a large amount of antibodies.
People with Waldenström's macroglobulinemia have ever greater amounts of B cells in their blood over time. This condition usually goes unnoticed until the body is no longer able to produce enough red blood cells and platelets. Initial symptoms may include weight loss, night sweats or severe fatigue. As the disease progresses, the spleen, the lymph nodes or even the bone marrow may be affected. The body also produces fewer healthy immune cells, severely weakening the immune system and making the condition life-threatening.
Ibrutinib aims to inhibit the production of B-cells and to stop the progression of Waldenström's macroglobulinemia. The drug is an option for people who did not benefit from previous treatments or who cannot have chemotherapy.
Ibrutinib is available in 140 mg capsules. Three capsules (420 mg) are taken once a day. Treatment should be stopped if it is not tolerated anymore or the disease progresses.
The standard treatment for people with Waldenström's macroglobulinemia is optimized individual therapy. The exact type of individual therapy will depend on whether it is an initial treatment or which treatments have been tried before. The therapy is individually adjusted by the doctor.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ibrutinib for adults with Waldenström's macroglobulinemia compared to standard therapies.
But the manufacturer did not provide any suitable data with which to answer this question.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of ibrutinib (Imbruvica).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ibrutinib - Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-04. Cologne: IQWiG. March 28, 2016.
IQWiG health information is written with the aim of helping
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