drugs

Imbruvica - ibrutinib

What is Imbruvica - ibrutinib used for and what is it used for?

Imbruvica is an anticancer medicine used in the treatment of two types of blood cancer: chronic lymphocytic leukemia and mantle cell lymphoma; both cancers involve a type of white blood cell called B lymphocytes. In chronic lymphocytic leukemia, Imbruvica is used in patients who have received at least one previous therapy and in patients whose tumor cells present genetic mutations (defined deletion 17p or TP53 mutation) that make them unsuitable for the combination of chemotherapy and immunotherapy (treatments that stimulate the immune system to kill cancer cells). In mantle cell lymphoma, Imbruvica is used in patients whose disease does not respond to previous therapy or has reappeared after previous treatment. Since the number of patients suffering from these diseases is low, these are considered rare and Imbruvica has been qualified as an "orphan medicine" (a medicine used in rare diseases). Imbruvica contains the active substance ibrutinib .

How is Imbruvica used - ibrutinib?

Imbruvica can only be obtained with a prescription and treatment should be started and continued under the supervision of a doctor experienced in the use of anticancer medicines. Imbruvica is available in 140 mg capsules. In chronic lymphocytic leukemia, the recommended dose is 3 capsules once a day, while in mantle cell lymphoma it is 4 capsules once a day. The medicine should be taken at the same time each day and treatment should be continued as long as the patient's health is improving or the patient is able to tolerate the side effects. If the patient takes other medicines that may interact with Imbruvica or if serious side effects occur, the dose may be reduced or therapy may be suspended as needed. Dose reduction is recommended in patients with mild to moderate hepatic impairment; Imbruvica is contraindicated in patients with severe impairment of liver function. For more information, see the summary of product characteristics (also part of the EPAR).

How does Imbruvica - ibrutinib work?

The active substance in Imbruvica, ibrutinib, works by blocking an enzyme called Bruton tyrosine kinase (Btk), which is mostly present in B lymphocytes. Btk promotes B-cell survival and promotes migration to the organs into which these cells normally divide . By blocking Btk, ibrutinib reduces the survival and migration of B lymphocytes, thereby delaying tumor progression.

What benefit has Imbruvica - ibrutinib shown during the studies?

In a main study involving 391 patients with chronic lymphocytic leukemia refractory to prior therapy or relapsing after termination, Imbruvica was shown to be more effective than ofatumumab (another anticancer medicine) in delaying tumor progression. After 1 year of treatment, approximately 66% of patients treated with Imbruvica survived without signs of disease progression, compared with approximately 6% of patients treated with ofatumumab. Imbruvica was also more effective than ofatumumab also in the subgroup of patients with 17p deletion / TP53 mutation. Imbruvica was examined in a main study involving 111 patients with mantle cell lymphoma refractory to previous therapy or relapsed at the end of the same. Imbruvica was not compared with other therapies in this study. The results of the study demonstrated the efficacy of Imbruvica, with a complete or partial response to therapy being observed in approximately 68% of patients: 21% of patients had a complete response (disappearance of all signs of cancer after therapy ) and 47% a partial response (the patient improved but some signs of the disease remained). The average duration of treatment response was 17.5 months.

What is the risk associated with Imbruvica - ibrutinib?

The most common side effects with Imbruvica (which may affect more than 1 in 5 people) are diarrhea, musculoskeletal pain (muscle and bone pain), upper respiratory tract infections (colds), ecchymosis, rash, nausea, pyrexia ( fever), neutropenia (decreased number of neutrophils, a type of white blood cell) and constipation. The most serious side effects are anemia (decrease in the number of red blood cells), neutropenia, pneumonia (infection of the lungs) and thrombocytopenia (reduction in the number of platelets). For the full list of all side effects reported with Imbruvica, see the package leaflet.

St. John's wort (a herbal medicine used for depression and anxiety) should not be used in patients treated with Imbruvica. Because Imbruvica can cause harm to the fetus, patients being treated with the medicine should use effective contraception during therapy and for 3 months after stopping treatment. For the full list of limitations, see the package leaflet.

Why has Imbruvica - ibrutinib been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Imbruvica's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that the efficacy of Imbruvica has been demonstrated in patients with chronic lymphocytic leukemia, including those with genetic mutations that contribute to a poor prognosis. The committee noted that Imbruvica is also effective in patients with mantle cell lymphoma refractory to a previous therapy or relapsed at the end of the same, which constitute a group with poor prognosis and with few other therapeutic options. Furthermore, the safety of the medicine was considered acceptable.

What measures are being taken to ensure the safe and effective use of Imbruvica - ibrutinib?

A risk management plan has been developed to ensure that Imbruvica is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imbruvica, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company will provide additional data on the benefits of Imbruvica in the treatment of mantle cell lymphoma from a study in which the medicine was compared with temsirolimus (another anticancer medicine) as well as additional information on the benefits of Imbruvica in the treatment of chronic lymphocytic leukemia from follow-up studies conducted at the end of the main study. Further information is available in the summary of the risk management plan.

Other information about Imbruvica - ibrutinib

On 21 October 2014, the European Commission issued a marketing authorization for Imbruvica, valid throughout the European Union. For more information about treatment with Imbruvica, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 10-2014.