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What Is TASIGNA?

A treatment option for Ph+ CML

If you've been diagnosed with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase, it's important to understand the disease—and your treatment options. One medication your doctor may prescribe is TASIGNA® (nilotinib) capsules.

 

How effective is TASIGNA?

TASIGNA has been studied for more than 10 years. In a clinical trial, TASIGNA has been shown to be more effective than GLEEVEC® (imatinib mesylate) tablets among a key set of patients:

 

Whether you are newly diagnosed with Ph+ CML or you are making the switch to TASIGNA, the goal of treatment is to help you achieve a deep molecular response (DMR). Your doctor may refer to this as molecular response (MR) 4.5. You’ll learn more about the path to MR4.5 below.

 

Considering TASIGNA, right from the start

If you’ve been recently diagnosed with Ph+ CML in chronic phase, your doctor may have you start on TASIGNA. Below are results from a clinical trial that compared TASIGNA to GLEEVEC among adults who were newly diagnosed with Ph+ CML.

Early response with TASIGNA at 3 months

In a clinical study, 9 out of 10 adult patients on TASIGNA achieved an early molecular response (BCR-ABL ≤10%) at 3 months.

 Early response with TASIGNA after 3 months vs. GLEEVEC

Early response is a milestone, which more patients reached with TASIGNA than with GLEEVEC. It’s also worth noting that patients who achieved a molecular response at 3 months (BCR-ABL ≤10%) were more likely to achieve a major molecular response (MMR) at 1 year (BCR-ABL ≤0.1%).

 

MMR means that the amount of BCR-ABL in your bone marrow is low, which is a good sign when you have Ph+ CML.

 

MMR at 1 year

Major molecular response at one year with TASIGNA vs. GLEEVEC

Twice as many adult patients who took TASIGNA achieved MMR (BCR-ABL ≤0.1%) 1 year into the clinical trial as patients who took GLEEVEC.

 

Sustained response to TASIGNA by 5 years

In a clinical study among newly diagnosed adult patients with Ph+ CML in chronic phase, more than half of those on TASIGNA achieved a DMR at 5 years. Your doctor may refer to this as MR4.5 (BCR-ABL ≤0.0032%).

 

Achieved DMR by 5 years

Deep molecular response at 5 years with TASIGNA vs. GLEEVEC

Importantly, no patients who achieved MR4.5 progressed from chronic phase to accelerated phase or blast phase at any time during the 5-year study. In the clinical trial, 2 patients who received TASIGNA progressed to either accelerated phase or blast crisis while 12 patients who received GLEEVEC progressed to either accelerated phase or blast crisis.

Switching from another medication to TASIGNA for Ph+ CML 

There are a number of reasons why it may be time to switch from another medication to TASIGNA for Ph+ CML:

  • Lack of response: Your body does not respond to treatment
  • Drug resistance: Over time, you lose your response to your medication. Your doctor may refer to this as drug resistance
  • Side effects: You experience side effects, such as diarrhea, nausea, and severe muscle cramps
  • Drug intolerance: Your side effects become so bothersome that they may keep you from taking your medication. Your doctor may determine that your body can no longer tolerate the side effects and switch you to TASIGNA

 

Clinical results among those switching to TASIGNA

In a clinical trial among patients who had taken GLEEVEC before switching to TASIGNA, TASIGNA was shown to be effective. Among the results with TASIGNA:

 

Major cytogenetic response (MCyR)

Fifty-one percent of Ph+ CML patients (164 of 321 patients) in chronic phase achieved MCyR. This means 0% to 35% of the cells in the bone marrow tested positive for the Philadelphia chromosome.

 

Major cytogenetic response (MCyR) in chronic phase of Ph+ CML with TASIGNA

 

Complete hematologic response (HR)

A complete HR is when white blood cells, platelets, and red blood cell counts have returned to a normal range. Almost 40% (55 of 137 patients) in the accelerated phase of Ph+ CML achieved HR.

 

Hematologic response (HR) in accelerated phase of Ph+ CML with TASIGNA

 

Time to achieve treatment milestones

In adult patients in chronic phase, the median time (the middle point of the range) to MCyR was 2.8 months (response time ranged from 1 to 28 months). In patients in the accelerated phase, the median time to HR was 1 month (response time ranged from 1 to 14 months).

 

In clinical trials with TASIGNA, the most common side effects in adults included:

  • Nausea
  • Headache
  • Itching
  • Diarrhea
  • Constipation
  • Vomiting
  • Rash
  • Tiredness
  • Fever
  • Cough
  • Muscle and joint pain
  • Night Sweats
  • Runny or stuffy nose, sneezing, sore throat

How TASIGNA works in your body

How TASIGNA works