Nilotinib (Tasigna) has received approval by the FDA for the treatment of Philadelphia chromosome positive chronic-phase chronic myeloid leukemia when it is first diagnosed.
The new indication, approved under the FDA's accelerated approval program, expands nilotinib's original indication for the treatment of the condition in adult patients whose disease had progressed or who could not tolerate other therapies.
In a single clinical trial of 846 patients with newly diagnosed Ph+ chronic-phase CML, patients received either nilotinib or imatinib until their disease worsened, or until unacceptable side effects developed. The study measured patients' major molecular response at 12 months and found that approximately 44% of patients who received nilotinib experienced a major molecular response, compared with 22% of those receiving imatinib.
When nilotinib was originally approved in October 2007, the FDA determined that the therapy placed patients at risk of the abnormal heart rhythm of QT prolongation.
In March 2010, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for the drug to help patients and health care professionals better understand this risk. The REMS includes an updated Medication Guide and a communication plan to help reduce medication errors involving drug-food interactions and incorrect dosing intervals.