Cycle Pharmaceuticals announces the launch of PHYRAGO, its first oncology product in the US. PHYRAGO is launched in partnership with Handa Therapeutics, LLC, and will be exclusively available through specialty pharmacy Onco360 with a specialty distribution network from McKesson, Cencora, and Cardinal Health.
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Cycle Pharmaceuticals launches its first oncology product, PHYRAGOtablets, in the US
PHYRAGO is a tyrosine kinase inhibitor indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and pediatric patients 1 year of age and older with Ph+ CML in chronic phase, and newly diagnosed Ph+ ALL.1
PHYRAGO is bioequivalent to Sprycel tablets,and has the unique clinical benefit of allowing patients to take proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs) concomitantly to help manage gastric acid disorders. To help patients with medication access, financial savings, and clinical support, Cycle Vita will be available to eligible* patients taking PHYRAGO.
“We are honored to introduce PHYRAGO as a new treatment option for people living with Ph+ leukemia,” said Steve Fuller, Chief Strategy Officer at Cycle Pharmaceuticals.
“We understand the daily challenges that come with managing Ph+ CML and Ph+ ALL, and our goal is to ease that burden, not just with an improved formulation of dasatinib, but through the individualized care and hands on support offered by our Cycle Vita program. By enabling more flexibility in co-medication and providing a dedicated support team, we’re committed to helping patients and their families navigate treatment with greater confidence and peace of mind.”
Cycle Pharmaceuticals has been empowering patients with rare diseases through its products and support hub since 2017.
- NITYR® (nitisinone) Tablets in 2017
- SAJAZIR™ (icatibant) Injection in 2021
- JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022
- TASCENSO ODT® (fingolimod) in 2023
- ORMALVI™ (dichlorphenamide) tablets in 2024
- VENXXIVA™ (tiopronin) Delayed-Release Tablets in 2025
- BAFIERTAM® (monomethyl fumarate) Delayed-Release Capsules in 2025
- HARLIKU™ (nitisinone) Tablets in 2025
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Indications
PHYRAGO™ is a kinase inhibitor indicated for the treatment of:
- Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
- Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance / intolerance to prior therapy including imatinib.
- Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
- 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
Warnings and Precautions:
Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor blood counts. Transfuse and interrupt PHYRAGO when indicated.
Fluid Retention: Fluid retention, including pleural effusions. Manage with supportive care and/or dose modification.
Cardiovascular Toxicity: Monitor for signs or symptoms and treat appropriately.
Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed.
QT Prolongation: Use PHYRAGO with caution in patients who have / may develop prolongation of the QT interval.
Severe Dermatologic Reactions: Severe mucocutaneous dermatologic reactions have been reported.
Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain hydration and correct uric acid levels prior to initiating treatment.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.
Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development.
Hepatotoxicity: Assess liver function before treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.
Adverse Reactions:
Common adverse reactions in adults include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
Common adverse reactions in pediatric patients include mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness.
Postmarketing Experience:
Post approval adverse reactions:
Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.
Drug Interactions:
Strong CYP3A4 Inhibitors and Strong CYP3A4 Inducers: Dose reduction may be necessary.
Antacids: Avoid concomitant use.
Use in Specific Populations:
Pregnancy: PHYRAGO can cause fetal harm. Advise a pregnant woman of the potential risk to a fetus.
Contraception: Should be used during treatment and for 30 days after the last dose.
Lactation: Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.
Pediatric Use: There is no data in children under 1 year of age. Adverse reactions associated with bone growth and development were reported and should be monitored closely. Refer to the full USPI for pediatric patients with difficulty swallowing tablets.
Geriatric Use: Patients over 65 and older may experience: fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, appetite disturbance, abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease. Monitor closely.
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