Novartis announced the European Commission (EC) has approved the inclusion of treatment-free Remission (TFR) data in the Tasigna (nilotinib) Summary of Product Characteristics (SmPC). TFR is the ability to maintain molecular response (MR) after stopping tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP).
"For more than 15 years, Novartis has been committed to improving upon the standard of care in Ph+ CML," Bruno Strigini, CEO, Novartis Oncology said. "With this EU approval, we are pleased that results of two studies from our large international Ph+ CML clinical trial program assessing Tasigna discontinuation, ENESTfreedom and ENESTop, now provide physicians with important clinical information for discontinuing therapy in certain patients."
The approval by the EC was based on efficacy and safety findings from the 48-week analyses of two open label trials, ENESTfreedom and ENESTop, which showed that more than 50% of Ph+ CML-CP patients who met the rigorous predefined response criteria of the trials were able to maintain TFR after stopping Tasigna in both in the first-line setting and after switching from Glivec (imatinib). No new major safety findings were observed in these studies at the 48-week analyses in patients treated with Tasigna beyond those in the known safety profile of Tasigna.
CML is a type of cancer in which the body produces cancerous white blood cells. Almost all patients with CML have an abnormality known as the Philadelphia chromosome, which produces a protein called BCR-ABL. BCR-ABL causes malignant white blood cells to proliferate. Worldwide, CML is responsible for approximately 10% to 15% of all adult cases of leukemia, with an incidence of one to two cases per 100,000 people per year.