What Is TASIGNA?

Since 2001, a class of prescription medications called tyrosine kinase inhibitors (TKIs) has helped transform Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) from a type of leukemia that was life-threatening into a manageable disease that more people are living with.

 

All this progress has led some people to talk about Ph+ CML-CP as a “good cancer.” But in reality, there’s no such thing. That’s why it’s important to make sure your blood is getting the treatment—and the attention—it deserves.

 

Effective among newly diagnosed patients and those switching

TASIGNA® (nilotinib) capsules is a prescription medication that has been proven effective among 2 key groups:

 

  • People who were newly diagnosed with Ph+ CML-CP. For clinical results, see the information below
  • People who switched to TASIGNA from another medication due to side effects or because they were no longer responding to their prior treatment. Learn more

 

Results among those newly diagnosed

In clinical trials, TASIGNA was shown to be an effective treatment for Ph+ CML-CP based on the following responses to the medication:

Early response with TASIGNA

Early response means that at 3 months your BCR-ABL levels are lower than when you started treatment.

  • BCR-ABL1 ≤10% means that 10 out of every 100 cells have the BCR-ABL1 gene

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Early response is a milestone, which more patients reached with TASIGNA than with GLEEVEC® (imatinib mesylate). In addition, patients who achieved a molecular response at 3 months (BCR-ABL1 ≤10%) were more likely to achieve a major molecular response (MMR) at 1 year (BCR-ABL1 ≤0.1%).

 

 

Twice as many achieved MMR with TASIGNA at 1 year 

MMR means that the amount of BCR-ABL1 in your bone marrow is 1000-fold lower than your baseline, when you started treatment. This is a good sign when you have Ph+ CML-CP.

  • In a clinical trial, twice as many adults who took TASIGNA achieved MMR (BCR-ABL1 ≤0.1%) 1 year into the clinical trial than patients who took GLEEVEC
  • With MMR, BCR-ABL1 is ≤0.1%. In this case, 1 out of every 1,000 cells has the BCR-ABL1 gene

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Sustained response to TASIGNA by 5 years

  • A clinical study showed that more than half of those on TASIGNA (151 of 282 patients or 54%) achieved a deep molecular response (DMR) by 5 years 
  • Your doctor may refer to this as MR4.5 (BCR-ABL1 ≤0.0032%). This means that 1 out of every 32,000 cells has the BCR-ABL1 gene

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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.

Common side effects 

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

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

 

Be sure to see the complete list of possible side effects of TASIGNA. Learn more

How TASIGNA works