Novartis Tasigna Bags FDA Approval

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.”