FDA Approves Nilotinib (Tasigna) for Second-Line CML

ROCKVILLE, Md., Nov. 1 -- The FDA has approved nilotinib (Tasigna) for Philadelphia chromosome-positive chronic myeloid leukemia that is refractory or resistant to imatinib (Gleevec) or other first-line treatments.
As part of the approval, the FDA stipulated that nilotinib carry a black box warning for "possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death."
The FDA based its decision on efficacy demonstrated in ongoing trials of nilotinib. It said responses in those trials were "associated with normalization of blood counts and bone marrow examinations." But the FDA said additional follow-up of patients was needed to determine the durability of those responses.
According to the FDA, patients may lower their chances for the heart problems by taking nilotinib without food, and by avoiding grapefruit products.
"Patients should also consult with their physician or other health care professional about avoiding other medications that can cause heart problems when taking [nilotinib]," the FDA said.
Moreover, patients with low blood potassium or magnesium should not use nilotinib.
The most common side effects in clinical trials included low blood counts, rash, headache, nausea and itching. Other possible serious side effects included liver damage, edema, and pancreas inflammation.
The FDA said women should not take the drug while pregnant, nor should they take it while breastfeeding.