What is Zydelig and what is it used for?
Zydelig is an anticancer medicine used to treat two types of blood cancer: chronic lymphocytic leukemia (a cancer affecting a type of white blood cell called "B lymphocytes") and follicular lymphoma (another type of cancer that affects B lymphocytes 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 cancer cells have genetic mutations (called 17p deletion or TP53 mutation) that make these people unsuitable for 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 substance idelalisib.
How is Zydelig used - idelalisib?
Zydelig can only be obtained with a prescription and treatment should 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 the side effects. If the patient experiences severe side effects, the treatment should be stopped and it can be resumed at 100 mg twice a day. For more For information, see the Summary of Product Characteristics (also part of the EPAR).
How does Zydelig - idelalisib work?
The active substance 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 cancers, where it allows cells to survive. tumors. By acting on this enzyme and blocking its effects, idelalisib causes the death of cancer cells, delaying or stopping the progression of the tumor.
What benefit has Zydelig - idelalisib shown during the studies?
In a main study involving 220 patients with previously treated chronic lymphocytic leukemia, Zydelig was shown to be more effective than placebo (a dummy treatment) in managing cancer when both the medicine and placebo were given in combination with another medicine. , rituximab: disease improvement was seen 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 cancer cells had a specific genetic mutation, making them inadequate for chemoimmunotherapy. Another main study evaluated treatment with Zydelig in subjects with different lymphomas, including 72 patients with follicular lymphoma whose disease had failed to respond to two previous therapies. The efficacy of Zydelig was demonstrated, as 54% of patients with follicular lymphoma responded fully or partially to treatment.
What is the risk associated with Zydelig - idelalisib?
The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections, neutropenia (decrease in the number of neutrophils, a type of white blood cell), diarrhea, increased levels of liver enzymes in the blood, erythema, fever and increased blood fat levels. Based on studies in animals, Zydelig can cause harm to the fetus. Therefore Zydelig is not recommended in pregnancy and women taking the medicine must use reliable contraceptive measures to avoid becoming pregnant during therapy and for 1 month after stopping it. It is also not known whether Zydelig can reduce the effectiveness of hormonal contraceptives. Women and their partners should therefore use a barrier method of contraception such as condoms. 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 effective in patients with chronic lymphocytic leukemia in the presence of a 17p deletion or TP53 mutation, making 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 added to the summary of product characteristics and package leaflet for Zydelig, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company will provide definitive results on the main ongoing studies with Zydelig in people with chronic lymphocytic leukemia and follicular lymphoma. Further information can be found in the summary of the risk management plan
Other information about Zydelig - idelalisib
On 18 September 2014, the European Commission granted a "Marketing Authorization" for Zydelig, valid throughout the European Union. For more information on Zydelig therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 09-2014.
The information on Zydelig - idelalisib published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
