Information for US patients

Understanding Ph+ CML and Ph+ ALL

Not actual patient disclaimer
Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and Ph+ acute lypmphoblastic leukemia (Ph+ ALL) are rare types of blood cancer (leukemia) caused by a genetic mutation called the Philadelphia Chromosome.1,2
Diagram showing a gene swap between chromosomes 9 and 22, creating the Philadelphia chromosome (BCR‑ABL1).

Figure 1. Formation of Philadelphia Chromosome3

What is the Philadelphia Chromosome?

The Philadelphia Chromosome is an error in the DNA that occurs when part of chromosome 9 and chromosome 22 swap places. The fusion creates a new gene, BCR::ABL1, which produces a cancer-causing protein BCR-ABL1.1,2

The BCR-ABL1 protein is always on, constantly sending out growth signals, and leads to uncontrolled growth of leukemia cells (or cancer).1,2

What does CML and ALL stand for?

CML and ALL describe the cancer, specifically its growth rate and affected cell type.4
Chronic

Slow growing

Myeloid

Cell type that gives rise to red blood cells, platelets, and granulocytes

Leukemia

Blood cancer

Acute

Slow growing

Lymphoblastic

Cell type that gives rise to red blood cells, platelets, and granulocytes

Leukemia

Blood cancer

Ph+ CML and Ph+ ALL explained

What is Ph+ CML?

CML is a rare, and slow progressing type of leukemia where the bone marrow makes too many white blood cells. Ph+ CML is a common form that affects approximately 90% of patients with CML, and typically affects middle-aged individuals.5

With good adherence, most patients with Ph+ CML and Ph+ ALL can stay on long‑term treatment that is personalized to their individual needs and lifestyle.6,7

What is Ph+ ALL?

Ph+ ALL occurs in approximately 20% to 30% of ALL patients and is more common in older individuals.8 If untreated, Ph+ ALL is aggressive and progresses rapidly, so it is important to start treatment soon after diagnosis.9

Treating Ph+ CML and Ph+ ALL

The goal of treatment is to stop the growth and spread of cancer. In the case of Ph+ CML and Ph+ ALL, one approach is to switch off the BCR-ABL1 protein.2,10

Tyrosine kinase inhibitors (TKIs), including PHYRAGO™ (dasatinib) tablets, are a class of cancer treatments that target the BCR-ABL1 protein to stop the spread of cancer while limiting damage to normal cells.2,10,11

Middle aged couple planting pot of pink flowers

References

1. American Cancer Society. (2025). What causes Chronic Myeloid Leukemia (CML)?. [online]. Available at: https://www.cancer.org/cancer/types/chronic-myeloid-leukemia/causes-risks-prevention/what-causes.html. [Accessed: December 8 2025].
2. Blood Cancer United. (2025). Acute lymphoblastic leukemia (ALL) treatment. [online]. Available at: https://bloodcancerunited.org/blood-cancer/leukemia/acute-lymphoblastic-leukemia-all/treatment. [Accessed: December 8 2025].
3. National Cancer Institute. (n.d.) Philadelphia chromosome. [online]. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/philadelphia-chromosome. [Accessed: December 8 2025].
4. Markman, M. (2022). Leukemia | City of Hope. [online]. Available at: https://www.cancercenter.com/cancer-types/leukemia/types. [Accessed: August 12 2025].
5. National Organization for Rare Disorders. 2018. Chronic Myelogenous Leukemia. [online]. Available at: https://rarediseases.org/rare-diseases/chronic-myelogenous-leukemia/. [Accessed: June 5 2025].
6. Sasaki K, Haddad FG, Short NJ, et al. 2023. Outcome of Philadelphia chromosome-positive chronic myeloid leukemia in the United States since the introduction of imatinib therapy—The Surveillance, Epidemiology, and End Results database, 2000–2019. Cancer. 129(23): 3805-3814. doi:10.1002/cncr.35038.
7. Rafei, H., Kantarjian, H. M., & Jabbour, E. J. 2019. Recent advances in the treatment of acute lymphoblastic leukemia. Leukemia & Lymphoma, 60(11), 2606–2621. doi:10.1080/10428194.2019.1605071.
8. Liu-Dumlao, T., et al. (2021). Philadelphia-positive acute lymphoblastic leukemia: current treatment options. Curr Oncol Rep. 14(5). Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC4199301/ [Accessed: May 20 2025].
9. Leukemia and Lymphoma Society. Acute Lymphoblastic Leukemia | Leukemia and Lymphoma Society. [online]. Available at: https://www.lls.org/leukemia/acute-lymphoblastic-leukemia. [Accessed: June 5 2025].
10. Blood Cancer United. (2025). Chronic myeloid leukemia (CML) treatment. [online]. Available at: https://bloodcancerunited.org/blood-cancer/leukemia/chronic-myeloid-leukemia-cml/treatment. [Accessed: December 8 2025].
11. PHYRAGO™ (dasatinib). Prescribing Information. Handa Therapeutics, LLC.

Indication and Important Safety Information
PHYRAGO Logo
Indication and Important Safety Information
PHYRAGO Logo

Indications

PHYRAGO™ is a prescription medicine used to treat:

  • Adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
  • Adults with Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including imatinib.
  • Adults with Ph+ acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment.
  • Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
  • Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Important Safety Information

Serious Adverse Reactions:

Low blood cell counts. Low blood cell counts are common with PHYRAGO and can be severe, including 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 PHYRAGO. Call your healthcare provider right away if you have a fever or any signs of an infection during treatment with PHYRAGO.

Bleeding problems. Bleeding problems are common with PHYRAGO. Sometimes these bleeding problems can be serious and 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, decreased alertness, headache or change in speech.

Your body may hold too much fluid (fluid retention). Fluid retention is common with PHYRAGO and can sometimes be severe. 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: swelling all over your body, weight gain, shortness of breath, especially if this happens with low levels of physical activity or at rest, dry cough and chest pain when taking a deep breath.

Heart and blood vessel (cardiovascular) problems. PHYRAGO may cause heart problems, including an abnormal heart rate, a heart attack, or small strokes that last only a few minutes or a few hours, called transient ischemic attacks (TIAs). TIAs are often a warning sign that you are at risk for a more serious stroke. Your healthcare provider will monitor the potassium and magnesium levels in your blood and your heart function.

Pulmonary Arterial Hypertension (PAH). PHYRAGO may cause high blood pressure in the vessels of your lungs. PAH may happen at any time during your treatment with PHYRAGO. Your healthcare provider should check your heart and lungs before and during treatment with PHYRAGO. Call your healthcare provider right away if you have shortness of breath, tiredness, or swelling all over your body (fluid retention).

Severe skin reactions. PHYRAGO may cause skin reactions that can sometimes be severe. Get medical help right away if you get a skin reaction with fever, sore mouth or throat, or blistering or peeling of your skin or in the mouth.

Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, and an abnormal heartbeat. Your healthcare provider may do blood tests to check you for TLS. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with PHYRAGO: nausea, vomiting, weakness, swelling, shortness of breath, muscle cramps and seizures.

Slowing of growth and development in children. Effects on bone growth and development in children have happened with dasatinib and can sometimes be severe. Your healthcare provider will monitor your child’s bone growth and development during treatment with dasatinib. Get medical help right away if your child develops bone pain.

Liver problems. PHYRAGO can cause liver problems. People who have had liver problems in the past may be at risk of getting liver problems with PHYRAGO. Your healthcare provider will monitor your liver function as needed during treatment with PHYRAGO. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including: stomach-area (abdominal) pain, yellowing of your skin or white part of your eyes, loss of appetite, bleeding, bruising or dark “tea-colored” urine.

Common Adverse Reactions:

The most common side effects in adults receiving dasatinib alone include: diarrhea, headache, skin rash, tiredness, nausea, muscle pain or shortness of breath.

The most common side effect in Pediatrics receiving dasatinib in combination with chemotherapy included mucositis (swelling and sores in the mouth or gut), febrile neutropenia (fever with signs of infection), fever, diarrhea, nausea, vomiting, muscle and bone pain, stomach pain, cough, headache, rash, tiredness, constipation, irregular heartbeat, high blood pressure, swelling, infections, low blood pressure, decreased appetite, hypersensitivity, shortness of breath, nosebleeds, peripheral neuropathy (damaged nerves in hands, feet or arms), and altered state of consciousness.

PHYRAGO may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you. Use contraception during and for 30 days after treatment. 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 PHYRAGO.

For more detailed information, please refer to the full Prescribing Information at https://phyrago.com/pi/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

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