Cycle Pharmaceuticals Secures Exclusive U.S. Rights to PHYRAGO, Novel Dasatinib Formulation for Leukemia Treatment
Key Insights
Cycle Pharmaceuticals has entered an exclusive U.S. commercialization agreement with Handa Therapeutics (search) for PHYRAGO (search), an FDA-approved dasatinib formulation for treating Philadelphia chromosome-positive chronic myeloid leukemia (search) and acute lymphoblastic leukemia.
PHYRAGO (search) represents a significant advancement over existing dasatinib therapy by allowing concomitant use with proton pump inhibitors and H2 receptor antagonists without clinically significant reduction in bioavailability.
The partnership will launch PHYRAGO (search) in September 2025 with comprehensive patient support services, marking Cycle Pharma's first oncology product and ninth commercial offering overall.
Cycle Pharmaceuticals has secured exclusive U.S. commercialization rights to PHYRAGO (search), a novel dasatinib formulation that addresses a critical drug interaction challenge in leukemia treatment. The agreement with Handa Therapeutics (search), LLC positions the FDA-approved therapy for launch in September 2025, targeting patients with Philadelphia chromosome-positive chronic myeloid leukemia (search) (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (search) (Ph+ ALL).
Addressing Critical Drug Interaction Limitations
PHYRAGO (search) represents a significant therapeutic advancement over the existing dasatinib standard of care, Sprycel®. The novel formulation eliminates the problematic drug interactions that have limited treatment options for patients requiring concurrent acid-suppressing medications. With Sprycel®, dasatinib drug exposure can be significantly reduced by more than 40% when administered with proton pump inhibitors (PPIs) and by more than 60% when used with H2 receptor antagonists (H2RAs).
In contrast, PHYRAGO (search) demonstrates no clinically significant reduction in dasatinib bioavailability when used concomitantly with PPIs or H2RAs. This pharmacokinetic advantage directly benefits patients on dasatinib therapy who are prescribed both medications, addressing a common clinical challenge in leukemia management.
Comprehensive Treatment Indications
PHYRAGO (search) is indicated as a kinase (search) inhibitor for treating multiple patient populations:
- Newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase
- Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
- Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy
Strategic Partnership and Market Launch
The collaboration marks Cycle Pharmaceuticals' second partnership with Handa Therapeutics (search) and represents the company's expansion into oncology. PHYRAGO (search) will become Cycle Pharma's ninth commercial product and first oncology offering, extending the company's expertise from rare genetic conditions into cancer treatment.
"We are excited about our second partnership with Handa, and the expansion of our patient support offerings to oncology. With PHYRAGO (search), Cycle Vita's expertise in providing individualized care to patients will soon be available to patients with leukemia," said Chikai Lai, SVP & Chief Commercial Officer at Cycle Pharmaceuticals.
Bill Liu, President and CEO of Handa Therapeutics (search), emphasized the therapeutic significance: "Handa is proud to continue its partnership with Cycle Pharmaceuticals in the commercialization of PHYRAGO (search), 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."
Patient Support Infrastructure
The September 2025 launch will include comprehensive patient support through Cycle Vita™, providing individualized product, educational, and financial assistance to adult patients with Ph+ CML and Ph+ ALL. This support system reflects Cycle Pharmaceuticals' established approach to serving underserved patient populations, now extended to the oncology setting.
Safety Profile and Clinical Considerations
PHYRAGO (search) carries important safety considerations consistent with dasatinib therapy, including risks of myelosuppression, fluid retention, cardiovascular toxicity, and pulmonary arterial hypertension. The therapy requires careful monitoring for QT prolongation and potential severe dermatologic reactions. Common adverse reactions include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.
The formulation addresses a significant unmet need in leukemia treatment by eliminating the drug interaction limitations that have complicated patient management with existing dasatinib therapy, potentially improving treatment outcomes for patients requiring concurrent acid-suppressing medications.