FDA approves small-molecule dasatinib formulation, expanding CML treatment options
Dr Michael J. Mauro explained that the FDA gave its nod in November 2025 to a generic, small-molecule version of dasatinib, the drug sold as Sprycel, for adult patients with Philadelphia-positive chronic myeloid leukemia (CML) in various disease phases.
The approval covers newly diagnosed chronic-phase CML as well as patients in accelerated or blast phases, and it also extends to Ph-positive acute lymphoblastic leukemia (ALL) when prior therapies such as imatinib have failed or caused intolerance.
According to Dr Mauro, the new formulation can be taken together with acid-reducing medicines like proton-pump inhibitors, which helps manage stomach-pH issues that can affect drug absorption.
The availability of alternative TKI formulations is expected to give clinicians more flexibility in sequencing therapy and may improve adherence for patients who need concomitant medications.
This writeup was produced by pharmadog from original reporting by onclive.
Original headline: “Dr Mauro on the Significance of Alternative TKI Formulations in CML”
read at onclive ↗
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