In clinical trials, the primary endpoint for patients in chronic phase was unconfirmed major cytogenetic response (MCyR). After a minimum follow-up of six months (median treatment duration 8.7 months), Tasigna produced MCyR in 40% of 232 chronic-phase patients evaluated for efficacy. The complete cytogenetic response in these patients was 28%.
For patients in accelerated phase, the primary endpoint was confirmed hematological response (HR). Complete HR was reported in 18% of patients in accelerated phase. (Accelerated-phase patients had a minimum follow-up of 4 months and a median treatment duration of 5.6 months).
The highest prior Gleevec dose was greater than or equal to 600 mg/day in 77% of patients with 44% of patients receiving doses of 800 mg/day or higher. In addition, 24 different mutations in Bcr-Abl were noted in 19% of chronic- phase and 25% of accelerated-phase CML patients who were evaluated for mutations.
Because taking Tasigna with food may increase the amount of drug in the blood, Tasigna should not be taken with food and patients should wait at least two hours after a meal before taking Tasigna. In addition, no food should be consumed for at least one hour after the dose is taken.
Tasigna(R) (nilotinib) capsules are indicated for the treatment of chronic-phase and accelerated-phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included Gleevec(R) (imatinib mesylate) tablets. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Tasigna important safety information
Tasigna prolongs the
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