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Iclusig® (ponatinib) is a kinase inhibitor indicated for the:
- Treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
- Chronic myelogenous leukemia is a disease in which the bone marrow makes too many white blood cells.
- Leukemia may affect red blood cells, white blood cells, and platelets.
- Signs and symptoms of chronic myelogenous leukemia include fever, night sweats, and tiredness.
- Most people with CML have a gene mutation (change) called the Philadelphia chromosome.
- Tests that examine the blood and bone marrow are used to detect (find) and diagnose chronic myelogenous leukemia.
- Certain factors affect prognosis (chance of recovery) and treatment options
Drugs known as tyrosine kinase inhibitors (TKIs) that target BCR-ABL are the standard treatment for CML. These include:
- Imatinib (Gleevec)
- Dasatinib (Sprycel®)
- Nilotinib (Tasigna®)
- Bosutinib (Bosulif®)
- Ponatinib (Iclusig®)
All of these drugs can have serious or even deadly interactions with other drugs, over the counter supplements, and even certain foods (such as grapefruit and pomegranate). Be sure that your doctor always has an up-to-date list of any medicines you are taking, including over-the-counter medicines, vitamins, and herbal supplements. You also need to check with your doctor before starting any new medicine, to be sure it is safe.
It is also important to understand that all of the TKIs can harm the fetus if taken during pregnancy. These drugs seem to work best on CML that is still in the chronic phase, but they also can help patients with more advanced disease for some time.
Ponatinib (Iclusig®) is a new TKI targeting the BCR-ABL protein. Because of risks of some serious side effects, this drug is only used to treat patients with CML if all of the other TKIs don’t work or if their leukemia cells have a certain gene change called the T315I mutation. This mutation (gene change) occurs in the leukemia cells of some CML patients who are treated with a TKI, and it prevents other TKIs from working. Ponatinib is the first TKI to work against CML cells that have this mutation.
This drug is a pill taken once a day.
Most side effects are mild and can include abdominal (belly) pain, headache, rash or other skin problems, and fatigue. High blood pressure is also fairly common, and it may need to be treated with a blood pressure drug. There is also a risk of serious blood clots that can lead to heart attacks and strokes, or block arteries and veins in the arms and legs. Rarely, blood clots in patients taking this drug have cut off circulation, and lead to an arm or leg needing to amputated (cut off). Surgery or some other procedure may be needed to treat these blood clots. The risk of serious blood clots is higher in older patients, those with certain risk factors, such as high blood pressure, high cholesterol, or diabetes, and those who have already had a heart attack, stroke, or poor circulation.
More rarely, this drug can also weaken the heart muscle, leading to a condition known as congestive heart failure. It can also cause liver problems, including liver failure, as well as pancreatitis (inflammation of the pancreas, which can lead to severe belly pain, nausea, and vomiting).
Now, let’s talk about the positive effects:
Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation. In the study, Iclusig was not compared with another treatment. The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response’ (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response’ (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
- among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
- among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
- among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
- among the patients with with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
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