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Treatment-Free Remission

Learn about the possibility of being treatment free.

Your doctor will work closely with you to determine if you may be eligible to stop taking TASIGNA® (nilotinib) capsules for Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Only your doctor can determine if you qualify to stop taking TASIGNA depending on whether you achieve certain treatment milestones and meet other criteria. Your doctor may refer to this as treatment-free remission (TFR).

 

Treatment-free remission is a goal for some adults

Based on TASIGNA data and a better understanding of Ph+ CML-CP, TFR has become a goal for some adults who take TASIGNA. One of the criteria for TFR is a very low level of leukemic cells in your body—less than or equal to (≤) 0.0032% of all the cells in your blood. Your doctor may call this a deep molecular response, or MR4.5.

 

Whether you are hoping to attempt TFR in the future, or your doctor has decided you are eligible to try TFR now, you need to follow your doctor’s instructions every step of the way.

 

Do not stop taking TASIGNA without discussing it first with your doctor.

TFR is a goal for some people with Ph+ CML-CP. Only TASIGNA has TFR data in its product label.

Only TASIGNA has TFR data in its product label for Ph+ CML-CP

TASIGNA belongs to a class of prescription medications called tyrosine kinase inhibitors (TKIs). TASIGNA is the only one with TFR data in its product label (also known as the prescribing information) for adults with Ph+ CML-CP.

 

Taking TASIGNA as prescribed plays a key part in being eligible to try TFR

Before your doctor can decide if TFR is right for you, it’s important to take TASIGNA exactly as prescribed for at least 3 years and go for regular blood tests. It’s also important to keep up with the dosing schedule that works for you. These are just some of the criteria that your doctor will examine to determine if you are eligible to attempt TFR.

Only your doctor can determine if you qualify to try TFR. Work with your doctor to stop treatment the right way.

Who is eligible for TFR?

TFR is the possibility for eligible adult patients with Ph+ CML-CP to come off treatment.

Eligibility to attempt TFR requires:
  • Treatment with TASIGNA for at least 3 years
  • Achieving certain treatment milestones in a particular timeframe
  • Maintaining certain molecular responses for at least one year immediately prior to attempting TFR
  • Confirmed presence of the most common types of BCR-ABL expression
  • No history of accelerated phase or blast crisis
  • No history of prior TFR attempts that resulted in relapse

 

For patients who previously took GLEEVEC® (imatinib), additional eligibility criteria include:

  • Having been treated with imatinib only prior to treatment with TASIGNA

 

Talk to your doctor if you have questions about what these criteria mean or how they apply to you.

How to team up with your doctor to ensure you stop treatment properly

  • Your healthcare provider will monitor your CML during treatment with TASIGNA to see if you are in a remission. After at least 3 years of treatment with TASIGNA, your healthcare provider may do certain tests to determine if you continue to be in remission. Based on your test results, your healthcare provider may decide if you may be eligible to try stopping treatment with TASIGNA. This is called Treatment Free Remission (TFR)
  • Your healthcare provider will carefully monitor your CML during and after you stop taking TASIGNA. Based on your test results, your healthcare provider may need to re-start your TASIGNA if your CML is no longer in remission
  • It is important that you are followed by your healthcare provider and undergo frequent monitoring to find out if you need to re-start your TASIGNA treatment because you are no longer in TFR. Follow your healthcare provider’s instructions about re-starting TASIGNA if you are no longer in TFR
TFR not only stands for treatment-free remission. It means a commitment to:  Testing. Frequent Monitoring. Restarting TASIGNA if you relapse.

TFR requires testing, testing, testing

If your doctor decides that you are eligible for TFR, you need to make a commitment to going for more frequent blood tests. If you do not go for the blood work you need, your disease could progress without your doctor being aware of it.

 

Be sure to go for all the blood tests your doctor requires. This will help your doctor closely monitor your results. Should your blood work show that you are no longer in remission, your doctor will want you to restart TASIGNA right away.

 

The testing routine while you are in TFR may include:

 

  • Year 1: Monitor every 4 weeks
  • Year 2: Monitor every 6 weeks
  • Year 3 and thereafter: Monitor every 12 weeks

 

Here are tests your doctor will likely recommend:

 

 

It’s important to discuss the results of your blood work with your doctor. Your results help your doctor see if you are in remission—and decide whether you are maintaining TFR or if you may need to restart TASIGNA. Learn more about monitoring.

Among those who qualified to stop treatment, clinical results for TFR.

Clinical results for maintaining TFR

 

Clinical trials were conducted among adults with Ph+ CML-CP who attempted TFR with TASIGNA.

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Here are results from a clinical trial that studied TFR among adults whose first treatment for Ph+ CML-CP was TASIGNA.

Maintained TFR

Almost 5 out of 10 patients who started on TASIGNA (93 of 190 patients, or 49%) maintained TFR for 96 weeks or nearly 2 years.

93 of 190 patients maintained TFR

Regained response after losing TFR and restarting TASIGNA

What about those patients who did not maintain TFR? At the end of this clinical trial, 88 patients lost TFR and restarted TASIGNA. In all, 98% of these patients (86 of 88 patients) were able to regain a major molecular response (MMR) at 24 weeks.

86 of 88 patients regained MMR after losing TFR and restarting TASIGNA

Here are results of a clinical trial that was conducted among adults who were taking GLEEVEC for more than 4 weeks before switching to TASIGNA.

Maintained TFR among those who switched to TASIGNA

More than 5 out of 10 patients who switched to TASIGNA from GLEEVEC (67 of 126 patients, or 53%) maintained TFR for 96 weeks or nearly 2 years.

67 of 126 patients maintained TFR

Regained response after losing TFR and then restarting TASIGNA

What about those patients who were unable to maintain TFR? At the end of this clinical trial, 56 patients lost TFR and restarted TASIGNA. More than 9 out of 10 of these patients (52 of the 56, or 93%) were able to regain a molecular response (MR4) at 48 weeks.
52 of 56 patients regained MR4 after losing TFR and restarting TASIGNA

Side effects in adult patients attempting treatment-free remission

If you and your healthcare provider decide that you can stop taking TASIGNA and try TFR, you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:

 

  • Muscle pain
  • Arm and leg pain
  • Joint pain
  • Bone pain
  • Spinal pain

 

Be sure to talk with your doctor about strategies to address these symptoms or any other side effects you experience after stopping treatment with TASIGNA.

If you experience a relapse, your doctor will have you restart TASIGNA

Restarting TASIGNA if you are no longer in TFR

The reason for the increase in testing during TFR is for your doctor to closely monitor your response. If your results show that you are no longer in remission, your doctor may want you to restart TASIGNA.

 

About 1 out of 2 people who stop taking TASIGNA to see if they can maintain TFR have to restart the medication. Keep in mind, if you are unable to maintain TFR, it is not because of anything you did or did not do.