The U.S. Food and Drug Administration (FDA) recently has approved an oral solution of the tyrosine kinase inhibitor, imatinib mesylate, called Imkeldi, to treat certain types of leukemia and other cancers. The new solution is an advanced liquid formulation of imatinib designed to provide dosing accuracy and is intended to help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), myelodysplastic syndrome/myeloproliferative disease, and gastrointestinal tumors.
The oral solution of imatinib mesylate was approved by the FDA for use in ALL and CML and in other cancers in adults and pediatric patients as young as age 1. The liquid solution provides a convenient and palatable strawberry flavor and a stable formulation that does not require refrigeration.
Despite the proven clinical benefits of imatinib, patient adherence can be an issue, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system.
The liquid oral solution of imatinib is indicated for the following:
- Treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive CML in chronic phase
- Treatment of patients with Philadelphia chromosome–positive CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
- Treatment of adults with relapsed or refractory Philadelphia chromosome–positive ALL
- Treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive ALL in combination with chemotherapy
- Treatment of adults with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements
- Treatment of adults with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown
- Treatment of adults with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization demonstration of CHIC2 allele deletion) and for patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who are FIP1L1-PDGFRα fusion kinase–negative or unknown
- Treatment of adulta with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans
- Treatment of patients with Kit (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors
- Adjuvant treatment of adults following resection of Kit (CD117)-positive gastrointestinal stromal tumors.
