FDA greenlights Novartis’ Tasigna for newly diagnosed CML
Basel – The US Food and Drug Administration (FDA) has approved Tasigna (nilotinib) 150 mg pills for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. A study is ongoing and further data will be required to determine long-term outcome. The US approval was based on results of the ENESTnd Phase III clinical trial, published in The New England Journal of Medicine (NEJM). In the head-to-head trial against Gleevec, Tasigna demonstrated improved treatment efficacy, as has been previously reported. The Bcr-Abl inhibitor reduced both the level of Philadelphia chromosome (cytogenetic response) as well as the anount of the Bcr-Abl protein (molecular response) faster than Gleevec, resulting in lower rates of cancer progression even as early as 12 months, with the drug well tolerated by patients. Reduction of Bcr-Abl is considered to be a critical therapeutic milestone associated with good long-term outcomes for patients with Ph+ CML. Fewer patients discontinued due to adverse events from the Tasigna 300 mg twice daily arm of the study compared to the Gleevec 400 mg once daily arm and no patients in the study had a prolongation of the QT interval >500 milliseconds. In addition, no sudden deaths occurred with either treatment. Tasigna can cause a possible life-threatening heart problem called QTc prolongation, which causes an irregular heartbeat, which may lead to sudden death. Regulatory submissions for Tasigna in the first-line indication are under way worldwide, with applications currently filed in the EU, Switzerland and Japan. At the beginning of June, Novartis’ competitor BristolMyers Squibb also reported positive results with its BCR-ABL kinase inhibitor dasatinib (Sprycel) in a head-to-head trial with Gleevec.