What is Zydelig - idelalisib used for?
Zydelig is a cancer medicine used to treat two types of blood cancer: chronic lymphocytic leukemia (a tumor that affects a type of white blood cell called "B lymphocyte") and follicular lymphoma (another tumor that affects B cells ). In chronic lymphocytic leukemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous therapy and in patients whose tumor cells present genetic mutations (called deletion 17p or TP53 mutation) that make these subjects unsuitable to chemotherapy and immunotherapy (treatments that stimulate the immune system to kill cancer cells). In follicular lymphoma, Zydelig is indicated for the treatment of patients whose disease has not responded to two previous therapies. Zydelig contains the active ingredient idelalisib .
How is Zydelig - idelalisib used?
Zydelig can only be obtained with a prescription and treatment must be prescribed by a doctor experienced in the use of anticancer therapies. Zydelig is available as 100 mg and 150 mg tablets. The recommended dose is 150 mg twice a day. Treatment should be continued as long as the patient shows signs of improvement or is able to tolerate side effects. If the patient has serious side effects, the treatment must be stopped and can be resumed at a dose of 100 mg twice a day. For more information, see the summary of product characteristics (also part of the EPAR).
How does Zydelig - idelalisib work?
The active ingredient in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta, which plays a role in the growth, migration and survival of white blood cells, but which is hyperactive in blood tumors, where it allows the survival of cells cancer. By acting on this enzyme and blocking its effects, idelalisib causes the death of tumor cells, delaying or interrupting tumor progression.
What benefit has Zydelig - idelalisib shown during the studies?
In a main study of 220 patients with chronic lymphocytic leukemia treated previously, Zydelig was shown to be more effective than placebo (a dummy treatment) in tumor management when both the medicine and the placebo were given in combination with another drug, rituximab: an improvement in the disease was observed in 75% of patients treated with Zydelig compared with 15% of patients treated with placebo. Zydelig was also more effective than placebo in the subgroup of patients whose tumor cells had a specific genetic mutation, which makes them inadequate for chemoimmunotherapy. Another main study evaluated treatment with Zydelig in subjects with different lymphomas, including 72 patients with follicular lymphoma in which the disease had not responded to two previous therapies. The efficacy of Zydelig has been demonstrated, since 54% of patients with follicular lymphoma responded to treatment either completely or partially.
What is the risk associated with Zydelig - idelalisib?
The most common side effects of Zydelig (which may affect more than 1 in 10 people) are infections, neutropenia (decreased number of neutrophils, a type of white blood cell), diarrhea, increased levels of liver enzymes in the blood, erythema, fever and increased levels of fat in the blood. Based on animal studies, Zydelig can cause fetal harm. Therefore Zydelig is not recommended in pregnancy and women taking the medicine should use reliable contraceptive measures to avoid pregnancy during therapy and for 1 month after its interruption. Furthermore, it is not known whether Zydelig can reduce the effectiveness of hormonal contraceptives. Women and their partners must therefore use a contraceptive barrier method such as a condom. For the full list of side effects and limitations, see the package leaflet.
Why has Zydelig - idelalisib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that data from the main studies, which were still ongoing at the time of the evaluation, showed high response rates with Zydelig in subjects with chronic lymphocytic leukemia and follicular lymphoma. The drug was also found to be effective in patients with chronic lymphocytic leukemia in the presence of a 17p deletion or TP53 mutation, which makes them unsuitable for chemoimmunotherapy. Finally, the safety of the medicine was considered acceptable. The Committee therefore decided that Zydelig's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Zydelig - idelalisib?
A risk management plan has been developed to ensure that Zydelig 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 Zydelig, including the appropriate precautions to be followed by healthcare professionals and patients. Furthermore, the company will provide definitive results on the main ongoing studies with Zydelig in subjects with chronic lymphocytic leukemia and follicular lymphoma. Further information is available in the summary of the risk management plan
More information on Zydelig - idelalisib
On 18 September 2014, the European Commission issued a marketing authorization for Zydelig, valid throughout the European Union. For more information on Zydelig therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2014.
