The drug ibrutinib (trade name: Imbruvica) has been approved in Germany since July 2015 for the treatment of Waldenström's macroglobulinemia in adults. As of June 2019 it can also be used in combination with rituximab.
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 fatigue. As the disease progresses, the spleen, the lymph nodes or the bone marrow may be affected. The body also produces fewer healthy immune cells. This can weaken the immune system so much that the condition becomes life-threatening.
Ibrutinib aims to inhibit the production of B cells and to stop the progression of Waldenström's macroglobulinemia. It is an option for people who did not benefit from previous treatments or who can't have have chemo-immunotherapy.
Ibrutinib is available in the form of 140 mg capsules as well as tablets of various doses: 140, 280, 420 and 560 mg. A daily dose of 420 mg is recommended for the treatment of Waldenström's macroglobulinemia. The dose can be adjusted based on the combination of medications used or if it is not well tolerated. Treatment should be stopped if it's no longer tolerated or if the cancer progresses.
The standard treatment for people with Waldenström's macroglobulinemia is optimized individual treatment. The exact type of individual treatment will depend on whether it is an initial treatment or which treatments have been tried before. The treatment is individually adjusted by the doctor, who also takes the patient's general condition into account.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of ibrutinib when taken alone (monotherapy) compared with the established standard treatments for Waldenström's macroglobulinemia. In 2019, the Institute wanted to look into the advantages and disadvantages of ibrutinib when used in combination with rituximab.
However, the manufacturer didn't provide any suitable data for either of these assessments.
This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of ibrutinib (Imbruvica) on its own (2016) and in combination with rituximab (2019).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ibrutinib – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A16-04. April 28, 2016. (IQWiG reports; Volume 386).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ibrutinib (Waldenström macroglobulinaemia) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-78. November 28, 2019. (IQWiG reports; Volume 846).
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