Tasigna (nilotinib), FDA-Approved for Philadelphia Chromosome Positive CML

Filed in archive Cancer , FDA Approvals , Treatment on October 30, 2007

Novartis Pharma's Tasigna (nilotinib) has recently been approved by the US FDA for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib (Gleevec).

FDA's approval of Tasigna includes a black box warning for possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death.

The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Responses are associated with normalization of blood counts and bone marrow examinations. Further follow-up of patients is needed to determine how long these responses will last.

The abnormal chromosome called the Philadelphia chromosome is located in the leukemic cells and is present in the majority of CML patients. CML accounts for 15 percent of all leukemias in adults.

Find more details from the FDA News.