Sprycel is approved for treatment of adults with chronic, accelerated and blast phase chronic myeloid leukemia (CML), CML in lymphoid blastphase and Philadelphia chromosome-positive acute lymfoblastic leukemia (Ph+ ALL). The patient needs to be resistant or intolerant to prior treatment. The authorization of Sprycel is based on an accelerated assessment procedure, and there are still no data that shows increased survival. Long term effects remain unknown as well.
There are currently no data from controlled trials. The effect of Sprycel is evaluated in phase II trials. In patients with chronic, accelerated and blast phase chronic myeloid leukemia (CML), CML in lymphoid blastphase and Philadelphia chromosome-positive acute lymfoblastic leukemia (Ph+ ALL), and who were resistant or intolerant to Glivec (imatinib), 3 trials have shown a hematological response in 36-81 % of the patients. These results were found at a follow-up after at least 6 months. In 2 studies a response in the Ph+ chromosome is reported in 29-45% of the patients at a follow-up after 8-10 months. 19-38 % of the patients experienced serious adverse effects, bleeding (7%), pleural effusion (4%) and diarrhea (4%) being the most frequent serious adverse effects. Cessation of treatment due to adverse effects was seen in 5-11% of the patients.
As there are no healing treatment options at this time for patients, who are resistant or intolerant to Glivec, IRF, finds, in the view of the documentation, that Sprycel should be tried in patients fulfilling the indication, until the results from controlled trials are available. There is a theorethical risk of development of resistance.
According to the Price List of Proprietary Medicinal Products (Danich Medicines Agency) the costs of one month treatment with Sprycel is per 15.01.07 44,204.75 Dkr. Sprycel is only dispensed in hospitals.
Sprycel was marketed 18 December 2006.