On July 21, 2025 Cycle Pharmaceuticals (Cycle Pharma) reported it has entered into an exclusive U.S. commercialization agreement with Handa Therapeutics, LLC (Handa), for PHYRAGO, an FDA approved drug for treating two types of leukemia, Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) (Press release, Handa Oncology, JUL 21, 2025, View Source [SID1234654463]). PHYRAGO will be Cycle Pharma’s first oncology product (its ninth commercial product) and will see the company extend its expertise in caring for patients living with chronic conditions into oncology.
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PHYRAGO is a novel formulation of Sprycel (dasatinib) that allows concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs),1 which can directly benefit patients on dasatinib therapy who are prescribed both medications.2
With Sprycel, the drug exposure of dasatinib can be significantly reduced by more than 40% and 60% when administered with PPIs and H2RAs, respectively.3 In contrast, with PHYRAGO, no clinically significant reduction in the bioavailability of dasatinib was observed following concomitant use with PPIs or H2RAs.1
Handa will be working closely with Cycle Pharma to launch PHYRAGO in September 2025. PHYRAGO will be launched with best-in-class patient support from Cycle Vita, providing individualized product, educational, and financial assistance* to adult patients with Ph+ CML and Ph+ ALL.
"We are excited about our second partnership with Handa, and the expansion of our patient support offerings to oncology. With PHYRAGO, Cycle Vita’s expertise in providing individualized care to patients will soon be available to patients with leukemia," says Chikai Lai – SVP & Chief Commercial Officer, Cycle Pharmaceuticals. Bill Liu, President and CEO of Handa Therapeutics, LLC, added "Handa is proud to continue its partnership with Cycle Pharmaceuticals in the commercialization of PHYRAGO, the first and only dasatinib product that can be taken concomitantly with PPIs and H2RAs. Handa is committed to bringing high quality oncology treatments such as PHYRAGO to patients."
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.
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: Cases of 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 in pediatric patients.
Hepatotoxicity: Assess liver function before initiation of treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.
Adverse Reactions:
Common adverse reactions (≥15%) include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
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: Dose reduction may be necessary.
Strong CYP3A4 Inducers: Dose increase 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: Monitor bone growth and development in pediatric patients.
Due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with pediatric information.
Geriatric Use: Patients over 65 and older are more likely to 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.
For more detailed information, please refer to the full Prescribing Information at www.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.
US-DAS-2500002 (June 2025)