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Cycle Pharmaceuticals Launches Its First Oncology Product, PHYRAGO™ (dasatinib) Tablets, in the US
16 Oct 2025
Drug Approval
DETROIT--(BUSINESS WIRE)--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.
Cycle Pharmaceuticals launches its first oncology product, PHYRAGO™ (dasatinib) tablets, 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® (dasatinib) tablets,2 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.1 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
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 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
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.
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:
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.
For more detailed information, please refer to the full Prescribing Information at 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-2500114 (October 2025)
References
Study NC9013-002. Center for Drug Evaluation and Research – Clinical Pharmacology Review(s). 2022. [online]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216099Orig1s000ClinPharmR.pdf . [Accessed May 21 2025].
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.
†Patients who do not wish to have Cycle Vita hub support may be eligible for Co-Pay.
-ENDS-
©2025 Cycle Pharmaceuticals Limited. All rights reserved.
PHYRAGO™ is a trademark of Handa Therapeutics, LLC.
Sprycel® is a registered trademark of Bristol-Myers Squibb Company.
NITYR® and TASCENSO ODT® are registered trademarks of Cycle Pharmaceuticals Ltd. in the United States.
Cycle Vita™, SAJAZIR™, JAVYGTOR™, and HARLIKU™ are trademarks of Cycle Pharmaceuticals Ltd. in the United States.
ORMALVI™ and VENXXIVA™ are trademarks of Torrent Pharma Inc. in the United States.
BAFIERTAM® is a registered trademark of Banner Life Sciences, LLC, a company of Cycle Pharmaceuticals.
About Cycle Pharmaceuticals
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle Pharma focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, we focus on multiple sclerosis. Cycle Pharma is headquartered in Cambridge, UK and has offices in Detroit, Michigan and Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X, LinkedIn and Facebook.
Handa is a specialty pharmaceutical company that focuses on developing high-quality medications that address significant unmet medical needs in oncology and neurology. Handa’s leadership has a proven track record of building effective teams, high quality product portfolios and successful pharmaceutical businesses. For more information, please visit www.handapharma.com.
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
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