Tasigna Approved by FDA for First LIne CML Treatment in US

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Below is the Novartis press release. You can find multiple stories about this

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MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE

FDA approves Tasigna® for newly diagnosed chronic myeloid leukemia patients,

data demonstrate major advance over Gleevec®

& #61623; Pivotal data from ENESTnd published in today's New England Journal of

Medicine

& #61623; In head-to-head trial, Tasigna reduced leukemia-causing protein faster

than Gleevec, resulting in lower rates of cancer progression even as early as 12

months1

& #61623; Regulatory submissions under way worldwide, with applications currently

filed in the EU, Switzerland and Japan

East Hanover, NJ, June 17, 2010 — Following a priority review, the US Food and

Drug Administration (FDA) has approved Tasigna® (nilotinib) 150 mg capsules for

the treatment of adult patients with newly diagnosed Philadelphia chromosome

positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 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. 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.

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).

& #8213;With the faster and deeper responses we are seeing with Tasigna, newly

diagnosed CML patients will have a new and more effective treatment option, "

said Hervé Hoppenot, President, Novartis Oncology.

Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes

production of cancer cells in Ph+ ,3. It is also active against a broad

spectrum of Bcr-Abl mutations associated with resistance to Gleevec4. 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.

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 months1. Deep reduction of Bcr-Abl, known as a major molecular

response, is considered to be a critical therapeutic milestone associated with

good long-term outcomes for patients with Ph+ CML5-7. Treatment with Tasigna led

to higher rates of both major molecular response and complete cytogenetic

response (reduction in the level of Philadelphia chromosome that is the hallmark

of this cancer) compared with Gleevec1.

The randomized, open-label, multicenter ENESTnd trial compared the efficacy and

safety of Tasigna versus Gleevec in adult patients with newly diagnosed Ph+ CML

in chronic phase1. It is the largest global randomized comparison of two oral

therapies ever conducted in newly diagnosed Ph+ CML patients in chronic phase.

Two patients on the nilotinib arm progressed to either accelerated phase or

blast crisis while 17 patients on the imatinib arm progressed to either

accelerated phase or blast crisis. In the study, Tasigna was well tolerated.

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. No

patients in the study had a prolongation of the QT interval >500 milliseconds1.

In addition, no sudden deaths occurred with either treatment4.

Regulatory submissions for Tasigna in the first-line indication are under way

worldwide, with applications currently filed in the EU, Switzerland and Japan.