How has the effectiveness of SPRYCEL® (dasatinib) been studied?

Based on the following two studies, the FDA approved the use of SPRYCEL in two groups of chronic phase (CP) Ph+ CML Chronic phase (CP) Ph+ CML: the first phase of CML; it can last for months or years; most people are diagnosed with CML during this phase  patients.

SPRYCEL vs Gleevec in previously untreated CP Ph+ CML patients

SPRYCEL in patients no longer benefitting from, or unable to tolerate, Gleevec

SPRYCEL was approved for use in newly diagnosed patients with CP Ph+ CML based on a head-to-head clinical study of 519 adults taking either SPRYCEL 100 milligrams (mg) once a day or Gleevec 400 mg once a day. This study was open-label, meaning that both the researchers and the participants knew which treatment was given.

The main goal of the study was to compare the two drugs, and to see if more patients achieved a confirmed CCyR Complete cytogenetic response (CCyR) When cells carrying the Philadelphia chromosome are undetectable  by 12 months with SPRYCEL versus Gleevec. Confirmed CCyR means that no cells with the Ph+ chromosome Ph+ chromosome: the chromosome abnormality that causes CML; pieces from 2 different chromosomes break off and fuse together to create this new abnormal chromosome  were detected when measured on two consecutive bone marrow tests at least 28 days apart during the study.

Major molecular response (MMR) was also measured.

Study Results

Within 1 year of treatment, SPRYCEL patients had higher rates of confirmed CCyR and MMR than patients taking Gleevec.

More people achieved a confirmed CCyR with SPRYCEL vs Gleevec

The percentage of patients who achieved a confirmed CCyR by 12 months was higher for patients taking SPRYCEL (77%) versus Gleevec (66%).

Patients taking SPRYCEL also achieved higher MMR rates (52%) versus Gleevec (34%).

Important Side Effect Information

This study also examined side effects in people newly diagnosed with chronic phase Ph+ CML taking SPRYCEL and those taking Gleevec.

The table below shows the most commonly reported side effects in this study.

Side effects reported in at least 10% of patients taking
SPRYCEL or Gleevec
Side Effect SPRYCEL 258 patients Gleevec 258 patients
Buildup of fluid in the body 23% 43%
Excess fluid around in the lungs 12% 0%
Swelling caused by fluid buildup in a specific part of the body 10% 36%
Swelling caused by fluid buildup throughout the body 3% 7%
Congestive heart failure/cardiac dysfunction 2% 1%
Fluid around the heart 2% <1%
High blood pressure in the arteries of the lungs 1% 0%
Fluid buildup in the lungs <1% 0%
Diarrhea 18% 19%
Headache 12% 10%
Musculoskeletal pain 12% 16%
Rash 11% 17%
Nausea 9% 21%
Fatigue 8% 11%
Muscle pain 6% 12%
Bleedinga 6% 5%
Within stomach and/or intestines 2% <1%
Other bleeding 5% 5%
Into the brain 0% <1%
Vomiting 5% 10%
Muscle inflammation 4% 19%

aA side effect of special interest that was reported in less than 10% of patients.

SPRYCEL vs Gleevec in previously untreated CP Ph+ CML patients

SPRYCEL in patients no longer benefitting from, or unable to tolerate, Gleevec

The study below was in patients with chronic phase CML who were resistant to, or unable to tolerate, Gleevec. If you have accelerated or blast phase CML, you should talk to your doctor about what to expect from SPRYCEL.

One hundred and sixty-seven patients were studied while taking SPRYCEL at a dose of 100 milligrams (mg) once daily. These people were part of an open-label clinical study testing different doses of SPRYCEL. An open-label study means that both researchers and participants knew which doses were given.

One of the main goals of the study was to measure major cytogenetic response (MCyR) in people taking SPRYCEL who were resistant to, or unable to tolerate, Gleevec. MCyR is a measurement that can help tell how well CML is responding to treatment.

Other responses that were measured were Progression-Free Survival Progression-Free Survival: the number of people living who maintained normal blood counts (also known as a complete hematologic response), maintained an MCyR, did not advance to a worse stage of CML  and Overall Survival. Overall Survival: the number of patients alive at the time the study results are recorded

Progression-Free Survival measures the number of people living who
  • maintained normal blood counts (also known as a complete hematologic response)
  • maintained an MCyR
  • did not advance to a worse stage of CML

Overall Survival is the number of patients alive at the time the study results are recorded.

Study Results

A majority (63%) of people with CP Ph+ CML in this study achieved an MCyR. Of these people, most (93%) maintained their response for 18 months.

At 2 years, 80% of the 167 people taking SPRYCEL 100 mg once daily had achieved Progression-Free Survival, meaning they were alive and had not progressed to a worse stage of disease. The Overall Survival rate was 91%, meaning 91% of patients were still alive.

Important Side Effect Information

SPRYCEL may cause serious side effects, including low blood cell counts, bleeding, fluid retention, and heart problems. Other common side effects of SPRYCEL include diarrhea, headache, cough, skin rash, fever, nausea, tiredness, vomiting, muscle pain, weakness, and infections. This is not a complete list of all side effects recorded in clinical studies with SPRYCEL. Tell your healthcare provider if you have any side effects while taking SPRYCEL.

Please click here for more Important Safety Information, including details on Possible Side Effects of SPRYCEL.

Important Safety Information about
SPRYCEL® (dasatinib)

It is not known if SPRYCEL is safe and effective in children younger than 18 years old.

Before you take SPRYCEL, tell your healthcare provider if you:

  • have problems with your immune system
  • have liver problems
  • have heart problems
  • are lactose intolerant
  • have any other medical conditions
  • are pregnant or planning to become pregnant. SPRYCEL may harm your unborn baby. Women should not become pregnant while taking SPRYCEL. Talk to your healthcare provider right away if you are pregnant or plan to become pregnant
  • are breast-feeding or plan to breast-feed. It is not known if SPRYCEL passes into your breast milk or if it can harm your baby. You and your healthcare provider should decide if you will take SPRYCEL or breast-feed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, antacids, and herbal supplements.

Especially tell your healthcare provider if you take:

  • medicines that increase the amount of SPRYCEL in your bloodstream, such as:
    • Nizoral® (ketoconazole)
    Sporanox® (itraconazole)
    Norvir® (ritonavir)
    Reyataz® (atazanavir sulfate)
    Crixivan® (indinavir)
    Viracept® (nelfinavir)
    Nefazodone (serzone®, nefadar)
    Invirase® (saquinavir)
    Ketek® (telithromycin)
    E-mycin® (erythromycin)
    Biaxin® (clarithromycin)
  • medicines that decrease the amount of SPRYCEL in your bloodstream, such as:
    • Decadron® (dexamethasone)
    Dilantin® (phenytoin)
    Tegretol® (carbamazepine)
    Rimactane® (rifampin)
    Luminal® (phenobarbital)
  • medicines whose blood levels might change by taking SPRYCEL, such as:
    • Sandimmune® (cyclosporine)
    Alfenta® (alfentanil)
    Fentanyl® (fentanyl)
    Orap® (pimozide)
    Rapamune® (sirolimus)
    Prograf® (tacrolimus)
    Ergomar® (ergotamine)

SPRYCEL® (dasatinib) is best absorbed from your stomach into your bloodstream in the presence of stomach acid. You should avoid taking medicines that reduce stomach acid, such as:

Tagamet® (cimetidine)
Pepcid® (famotidine)
Zantac® (ranitidine)
Prilosec® (omeprazole)
Protonix® (pantoprazole sodium)
Nexium® (esomeprazole)
AcipHex® (rabeprazole)
Prevacid® (lansoprazole)

Medicines that neutralize stomach acid, such as Maalox® (aluminum hydroxide/magnesium hydroxide), Tums® (calcium carbonate), or Rolaids® (calcium carbonate and magnesia), may be taken up to 2 hours before or 2 hours after SPRYCEL.

Since SPRYCEL therapy may cause bleeding, tell your healthcare provider if you are using blood thinner medicine, such as Coumadin® (warfarin sodium) or aspirin.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Take SPRYCEL exactly as prescribed by your healthcare provider

  • Take SPRYCEL with or without food. Try to take SPRYCEL at the same time each day
  • Swallow SPRYCEL tablets whole with water. Do not break, cut, or crush the tablets
  • You should not drink grapefruit juice while taking SPRYCEL

SPRYCEL may cause serious side effects, including:
  • Low Blood Cell Counts: SPRYCEL may cause low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with SPRYCEL. Call your healthcare provider right away if you have a fever or any signs of an infection while taking SPRYCEL.
  • Bleeding: SPRYCEL® (dasatinib) may cause severe bleeding that can lead to death. Call your healthcare provider right away if you have:
    • - unusual bleeding or bruising of your skin
    • - bright red or dark, tar-like stools
    • - a decrease in your level of consciousness, headache, or change in speech
  • Your body may hold too much fluid (fluid retention): In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you get any of these symptoms during treatment with SPRYCEL:
    • - swelling all over your body
    • - weight gain
    • - shortness of breath and cough
  • Heart problems: SPRYCEL may cause an abnormal heart rate, heart problems, or a heart attack that can lead to death. Your healthcare provider will monitor the potassium and magnesium levels in your blood, and your heart function.
  • Pulmonary Arterial Hypertension (PAH): SPRYCEL may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with SPRYCEL. Your healthcare provider should check your heart and lungs before and during your treatment with SPRYCEL. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention)

Other common side effects of SPRYCEL therapy include:

  • diarrhea
  • headache
  • cough
  • skin rash
  • fever
  • nausea
  • tiredness
  • vomiting
  • muscle pain
  • weakness
  • infections

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of SPRYCEL. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

Please read the Patient Information in the full Prescribing Information.