The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates. The study is ongoing and further data will be required to determine long-term outcome.
Novartis claimed that with this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Gleevec (imatinib mesylate) tablets, providing a major advance for patients with this blood cancer.
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML(2,3). It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Gleevec. The first clinical trials of Tasigna began only 21 months after its discovery, with the drug receiving its first regulatory approval as a second-line treatment in 2007.
The US approval was based on results of the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, which were published today in The New England Journal of Medicine (NEJM).
The randomised, open-label, multicenter ENESTnd trial compared the efficacy and safety of Tasigna versus Gleevec in adult patients with newly diagnosed Ph+ CML in chronic phase
Novartis said that in its pivotal head-to-head trial against Gleevec, Tasigna demonstrated improved treatment efficacy, as has been previously reported. Tasigna reduced Bcr-Abl faster than Gleevec, resulting in lower rates of cancer progression even as early as 12 months.
Regulatory submissions for Tasigna in the first-line indication are under way worldwide, with applications currently filed in the EU, Switzerland and Japan.
Herve Hoppenot, president of Novartis Oncology, said: “With the faster and deeper responses we are seeing with Tasigna, newly diagnosed CML patients will have a new and more effective treatment option.”