What is Sprycel?
Sprycel is a medicine that contains the active substance dasatinib. It is found in the form of white tablets (round: 20 and 70 mg; ovals: 50 and 100 mg).
What is Sprycel used for?
Sprycel is an anticancer medicine. It is indicated for the treatment of adults with leukemia (cancer of white blood cells):
- it is used in chronic myeloid leukemia (CML), a type of leukemia in which granulocytes (a type of white blood cell) proliferate unchecked, at all stages of the disease (chronic, accelerated and blast). Sprycel is used in patients with intolerance or resistance to other treatments, including imatinib (another anticancer medicine);
- it is also used in acute lymphoblastic leukemia (ALL), a type of leukemia in which lymphocytes (another type of white blood cells) reproduce too quickly, or in CML in blast phase, when patients are "Philadelphia positive chromosome" (Ph + ). This means that some of their genes have reorganized to form a special chromosome, called the Philadelphia chromosome. This chromosome produces an enzyme that leads to the development of leukemia. Sprycel is used when patients are intolerant, or when their disease is unresponsive, to other treatments.
Because the number of patients with these two forms of leukemia is low, the diseases are considered "rare" and Sprycel was designated an "orphan medicine" (a drug used in rare diseases) on December 23, 2005.
The medicine can only be obtained with a prescription .
How is Sprycel used?
Sprycel therapy should be initiated by a physician experienced in the diagnosis and treatment of leukemia.
Sprycel should be taken once a day, regularly in the morning or evening. For chronic phase CML, the initial dose is 100 mg. For advanced phase CML (accelerated or blast) and for Ph + LLA it is 140 mg. The dose can be increased or decreased based on the patient's response to the medicine. Therapy should be continued until the disease gets worse or the patient is intolerant to the drug. Patients should be monitored during treatment to control blood levels of platelets (blood constituents that promote clotting) and neutrophils (white blood cells
fighting the infection). If these values change or some side effects are observed, doctors may recommend a lower dose or a break from treatment. Sprycel can be taken with or without food, but the tablets must be swallowed whole. For more details, see the summary of product characteristics (also included with the EPAR).
How does Sprycel work?
Dasatinib, the active substance in Sprycel, belongs to a class of medicines called "protein kinase inhibitors". These compounds act by inhibiting a class of enzymes known as protein kinases. Dasatinib acts mainly by inhibiting the protein kinase called "BCR-ABL" kinase. This enzyme is produced by leukemic cells and causes them to proliferate uncontrollably. Sprycel helps to control the multiplication of leukemic cells by inhibiting, together with other kinases, the BCR-ABL kinase.
What studies have been carried out on Sprycel?
The five main studies on Sprycel, taken twice a day, involved 515 patients, each of whom had previously undergone treatment with imatinib, which had not worked or to which they had developed resistance. In none of these studies was a head-to-head comparison between Sprycel and another drug expected. Two studies were performed on chronic phase CML (198 and 36 patients), one on accelerated phase CML (120 patients), one on myeloid blast phase CML (80 patients) and one on CML in the lymphoid blast phase and Ph + ALL. (81 patients).
Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph + ALL.
All these studies evaluated the patients' responses by measuring the amount of white blood cells and blood platelets, to see if they returned to normal levels, and measuring the number of white blood cells containing the Philadelphia chromosome, to see if it decreased.
What benefit has Sprycel shown during the studies?
In the largest main study of patients with chronic phase CML, 90% of patients responded to treatment, with blood levels of platelets and white blood cells returning to normal pre-defined values. In patients with other stages of CML (accelerated, myeloid blast and lymphoid blast) and in the ALL the complete response was observed in a percentage of patients between one quarter and one third. Furthermore, in the five main studies a percentage of patients between one third and two thirds showed a reduction in the number of white blood cells containing the Philadelphia chromosome. In further studies, Sprycel taken once or twice a day revealed the same efficacy rate, but the daily dose produced fewer side effects.
What is the risk associated with Sprycel?
During the studies the most frequent side effects reported with Sprycel (seen in more than 1 patient in 10) were: infection, headache, hemorrhage, pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), cough, diarrhea, vomiting, nausea (feeling sick), abdominal pain, rash, musculoskeletal pain (joint and muscle pain), fluid retention, fatigue, superficial edema (swelling), pyrexia (fever), neutropenia (low number of neutrophils ), thrombocytopenia (low number of platelets) and anemia (low number of red blood cells). For the full list of all side effects reported with Sprycel, see the Package Leaflet.
Sprycel should not be used in people who are potentially hypersensitive (allergic) to dasatinib or any of the other components.
Why has Sprycel been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Sprycel outweigh its risks in the treatment of adults with CML in chronic, accelerated or blast phase and in the treatment of resistant adults with Ph + ALL and lymphoid CML, resistant or intolerant to previous therapies. The committee therefore recommended that Sprycel be given marketing authorization.
More information on Sprycel:
On November 20, 2006, the European Commission granted Sprycel a marketing authorization valid throughout the European Union to Bristol-Myers Squibb Pharma EEIG.
The summaries of the opinions of the Committee for Orphan Medicinal Products on Sprycel are available here (CML) and here (LLA).
The full EPAR for Sprycel can be found here.
Last update of this summary: 07-2009.
