Introduction

Ibrutinib (trade name: Imbruvica) has been approved in Germany since October 2014 for the treatment of chronic lymphocytic leukemia (CLL). It can be used for the first-line treatment of CLL in adults, and as a subsequent treatment for people who have had other treatment that was unsuccessful. Ibrutinib can be used on its own or in combination with other medications.

CLL is a rare type of cancer. It typically arises when B cells of the immune system mutate and start multiplying uncontrollably in the blood, bone marrow and lymphatic system. If CLL reaches an advanced stage, it may also spread to organs such as the liver or spleen.

Ibrutinib aims to stop the leukemia cells from multiplying in order to prevent CLL from progressing.

Application

Ibrutinib is available in 140 mg capsules. Three capsules (420 mg in total) are taken once a day.

If ibrutinib is used as first-line treatment, it can be taken either on its own (monotherapy) or in combination with the medication obinutuzumab. If ibrutinib is used as a subsequent treatment, it can be taken either on its own or in combination with the medications bendamustine and rituximab.

Treatment with ibrutinib should be stopped if it is no longer tolerated or CLL progresses.

Other treatments

Depending on their situation, adults with CLL may have individually optimized chemotherapy, a combination of chemotherapy and immunotherapy, treatment with the drug idelalisib, or best supportive care (BSC). BSC should be tailored to the patient’s individual needs, relieve symptoms such as pain, and improve their quality of life.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether ibrutinib has any advantages or disadvantages in the treatment of CLL when compared with the current standard treatments.

In 2016, the manufacturer provided data for the following groups:

  • Ibrutinib as monotherapy for people who have had treatment for CLL and are unable to have chemotherapy
  • Ibrutinib as combination therapy for people who have had treatment for CLL and can have chemotherapy

In 2019, IQWiG looked into whether ibrutinib has any advantages or disadvantages when used in combination therapy for the treatment of CLL in people who have not had any previous treatment for CLL. The manufacturer only provided suitable data for people who are not able to have chemo-immunotherapy.

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More information

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).