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Monitoring Treatment

TASIGNA

Periodic Ph+ CML testing is an important part of treatment

Your doctor may recommend Ph+ CML testing every 3 months to help manage your disease, see if you’re reaching your treatment milestones, and decide if changes to your therapy are needed.

 

Hematologic Tests

Cytogenetic Tests

Molecular Tests

This is a blood test that counts the number of white blood cells, red blood cells, and platelets in your blood.

 

If your blood cell counts have returned to within the normal range, you have achieved what is called a complete hematologic response (CHR).

In cytogenetic testing, laboratory technicians look at samples of your bone marrow or blood under a microscope and count the number of cells that contain the Ph (Philadelphia) chromosome.

 

If no cells with the Ph chromosome are found, it is called a complete cytogenetic response (CCyR).

A PCR (polymerase chain reaction) test requires a sample of blood or bone marrow. It is the most sensitive kind of test available for monitoring response to Ph+ CML treatment. A PCR test can find 1 leukemic cell in at least 100,000 normal cells. If the lab results are standardized to the international scale (IS), you may sometimes see this test referred to as IS-PCR.


A major molecular response (MMR) means that the amount of BCR-ABL1 found in the bone marrow sample or blood sample is low. PCR testing can determine if you’ve achieved an MMR.

The goal of your treatment is to lower the number of leukemia cells in your body at specific time points.

Your treatment milestones

Throughout your treatment, the amount of leukemic cells in your body may drop by levels of 10. This is called a log reduction. Periodic testing will let you and your doctor know whether you are reaching these milestones in the recommended timeframe.

 

When a patient does not respond to treatment with GLEEVEC® (imatinib mesylate), or loses their response over time, the patient may be experiencing drug resistance.

For example, some Ph+ CML patients who take GLEEVEC® (imatinib mesylate) to treat their Ph+ CML experience drug resistance. Over time, the BCR-ABL1 protein, the signal that tells your body to produce too many white blood (leukemic) cells, can change or mutate. When this happens, GLEEVEC can stop working to block the creation of leukemic cells.

 

Periodic testing will determine if you are reaching your treatment goals. If you stop responding to treatment, you may be resistant to GLEEVEC.

TASIGNA may be appropriate for patients resistant to GLEEVEC

If it’s confirmed that you’re resistant to GLEEVEC, your doctor may recommend switching therapy. Your doctor will determine if TASIGNA is right for you.

 

Demonstrated response for patients changing to TASIGNA

In a clinical trial of patients who had taken GLEEVEC® (imatinib mesylate) before changing to TASIGNA, TASIGNA was shown to be effective:

Major Cytogenetic Response (MCyR)
51% of Ph+ CML patients in chronic phase achieved major cytogenetic response (MCyR). This means 0%-35% of the cells in the bone marrow test positive for the Philadelphia chromosome.

Major Cytogenetic Response (MCyR)


Hematologic response (HR)

39% of patients in accelerated phase achieved hematologic response (HR).

 Hematologic response (HR)


Time to Achieve Treatment Milestones

In patients in chronic phase taking TASIGNA, the median time to MCyR was 2.8 months (range 1-28 months), and in patients in accelerated phase taking TASIGNA, the median time to hematologic response was 1 month (range 1-14 months).

 Time to Achieve Treatment Milestones

What does drug intolerance mean?

In rare cases, certain side effects may make it difficult for patients to stay on their Ph+ CML medication. Patients who can no longer stay on treatment because of side effects are said to have drug intolerance.

 

  • Some side effects can go away with time, can be managed with help from your doctor, or can be tolerated
  • Some side effects may be damaging to your health or may be so bothersome they keep you from taking your treatment as prescribed
  • It’s very important that you talk to your doctor or nurse about any side effects you may be experiencing while taking TASIGNA or another Ph+ CML treatment.
    Do not change your dose of TASIGNA or stop taking it without talking to your doctor first.

How is TASIGNA different from GLEEVEC?

TASIGNA was intentionally designed in a laboratory environment to bind to the BCR-ABL1 protein better than GLEEVEC. The connection between TASIGNA in vitro data and its effectiveness has not been established.

 

After 5 years in a clinical trial, 99% of patients taking TASIGNA and 95% of patients treated with GLEEVEC did not progress to accelerated phase or blast crisis phase.*

Twice as many newly diagnosed patients who took TASIGNA achieved a major molecular response (MMR) at one year (44%) as patients who took GLEEVEC (22%).

TASIGNA may work for some patients who are no longer benefiting from other Ph+ CML therapies, including GLEEVEC.

 

*Based on estimated time to progression to AP or BC for patients on core treatment during the pivotal trial.

 

TASIGNA is a prescription medicine used to treat adults who have:

  • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)

  • Ph+ CML in chronic phase and accelerated phase who are no longer benefitting from, or did not tolerate, other treatment including GLEEVEC. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)