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What Is TASIGNA?

Proven effective in treating Ph+ CML.

For details on clinical results with TASIGNA® (nilotinib) capsules for newly diagnosed patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), see the information below.

 

If you are already taking another medication for Ph+ CML-CP, learn why your doctor may recommend switching to TASIGNA. See reasons to switch.

 

A class of prescription medications called tyrosine kinase inhibitors (TKIs) has helped transform Ph+ CML-CP from a type of leukemia that was life-threatening into a manageable disease that more people are living with.

 

TASIGNA is a TKI that has treated approximately 28,000 people in the United States with Ph+ CML-CP since its approval in 2007.

 

While some people talk about Ph+ CML-CP as a “good cancer,” 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.

Among newly diagnosed patients, TASIGNA has been studied for 10 years

Among 2nd-generation TKIs approved for Ph+ CML-CP:

 

  • Only TASIGNA has 10 years of clinical trial data among newly diagnosed patients
  • Only TASIGNA has 10 years of data tracking treatment milestones among newly diagnosed patients 

 

Treatment milestones include:

 

Among those whose first treatment was TASIGNA: 10 years of data from clinical trials

More patients achieved early molecular response with TASIGNA

Early molecular response means that at 3 months your BCR-ABL1 levels are lower than when you started treatment.

  • In a clinical study, 9 out of 10 adults (234 of 258 patients) on TASIGNA achieved an early molecular response (BCR-ABL1 ≤10%) at 3 months
  • BCR-ABL1 ≤10% means that 10 out of every 100 cells have the BCR-ABL1 gene

Early molecular response is a milestone, which more patients reached with TASIGNA than with GLEEVEC® (imatinib). 

Twice as many achieved a MMR with TASIGNA at 1 year

Major molecular response (MMR) means that the amount of BCR-ABL1 in your bone marrow is 1,000-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 1000 cells has the BCR-ABL1 gene
  • Many patients who achieved MMR (BCR-ABL1 ≤0.1%) at 1 year achieved an early molecular response (BCR-ABL1 ≤10%) at 3 months

More patients achieved DMR with TASIGNA at some point over 5 years

  • A clinical study showed that more than half of those on TASIGNA (151 of 282 patients or 54%) achieved DMR at some point over 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 or fewer has the BCR-ABL1 gene

TASIGNA patients in chronic phase had fewer progressions

    Importantly, no patients who achieved MR4.5 progressed from chronic phase to accelerated phase or blast phase at the time of the analysis. 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.

    More patients achieved DMR at some point over 10 years

    TASIGNA has data showing that more than 60% of patients (172 of 282 patients) achieved MR4.5 at some point over 10 years.

    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 review information about the serious and most common side effects of TASIGNA. Learn more

    How TASIGNA works

    When you have Ph+ CML, the BCR-ABL protein sends a signal that causes the bone marrow to start making too many immature, damaged white blood cells. These immature, damaged white blood cells—also called leukemic cells—grow abnormally.
    TASIGNA targets and binds to the BCR-ABL protein that causes uncontrolled cell growth.
    During in vitro studies (studies conducted in test tubes), TASIGNA was shown to bind to and stabilize the inactive formation of the BCR-ABL protein.