Dr Mauro on the Significance of Alternative TKI Formulations in CML

“We have an [FDA-approved] formulation of dasatinib...which now allows patients to have concomitant therapy to block stomach acid and correct for stomach pH through histamine blockade or more commonly PPI.”

Michael J. Mauro, MD, an attending physician at Memorial Sloan Kettering Cancer Center, discussed how the November 2025 FDA approval of the generic, small-molecule formulation of dasatinib and the development of alternative TKI formulations have affected the treatment of patients with chronic myeloid leukemia (CML).

The approval of small-molecule agent referencing dasatinib (Sprycel) was specifically approved for adult patients with newly diagnosed Philadelphia chromosome (Ph)-positive CML in chronic phase; adult patients with chronic, accelerated, or myeloid/lymphoid blast phase, Ph-positive CML with resistance or intolerance to prior therapy including imatinib (Gleevec); and adult patients with Ph-positive acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. The agent is also indicated for pediatric patients 1 year of age and older with Ph-positive CML in chronic phase.

Mauro began by discussing the numerous TKI approvals that have been made available for patients with CML, highlighting alternative formulations in this space. He specifically highlighted the November 2024 FDA approval of nilotinib (Danziten) tablets with no mealtime restrictions for select patients with CML. Moveing to the more recent dasatinib approval, he underscored that this formulation enables patients with CML who are undergoing concomitant therapy to block stomach acid to overcome common barriers with TKI treatment, he added. Mauro mentioned that the small-molecule formulation of dasatinib circumvents issues with adherence and absorption that often come with TKI treatment when patients are receiving concomitant treatments like proton pump inhibitors (PPIs).

Mauro then looked to the future of TKIs in CML, pointing out new, oral liquid formulations of imatinib, a formulation that he said would be especially useful for pediatric patients who struggle with oral pills. Mauro closed by noting that the future of the CML treatment paradigm is bright with other alternative formulations potentially coming down the pike. Developing new TKIs and optimizing the ones already available remain equally important, he concluded.