Dr Mauro on the Significance of the FDA Approval of Orally Disintegrating Nilotinib Tablets for CML

“Drugs [like orally disintegrating nilotinib tablets] make it more likely that a patient is going to get the right amount of the drug in the easiest way without interruption of their quality of life, daily routine, and concomitant medications. It’s a nice advance to see these kinds of drugs developed.”

Michael J. Mauro, MD, an attending physician at Memorial Sloan Kettering Cancer Center, discussed the June 2026 FDA approval of the orally disintegrating tablet formulation of nilotinib (Cavhanza) for the treatment of select patients with chronic myeloid leukemia (CML). In addition to discussing the newly approved formulation of nilotinib and how it operates, Mauro explained why this approval matters and how patients will benefit from the regulatory decision.

Mauro began by noting the wave of biosimilars and alternative formulations of TKIs that have recently been approved or are in development for CML management, mentioning the liquid forms of imatinib (Gleevec) and biosimilars of dasatinib (Sprycel). He then discussed the orally disintegrating tablet formulation of nilotinib and what makes it unique. This formulation has a proprietary way of delivering nilotinib to patients with CML, Mauro added, noting that the oral tablets use a bioequivalent amorphous dispersion of the drug instead of native nilotinib compounds.

Additionally, the oral tablet formulation of nilotinib contains a lower dose than other formulations of the TKI, an aspect of the formulation that may be safer for patients, he said. Mauro then dove into the aspects of patient quality of life that the oral nilotinib formulation can improve. First, the oral tablet formulation might allow patients to no longer require fasting and food exclusion when receiving nilotinib, Mauro said. Removal of food exclusion for patients with CML might in turn improve adverse effects like QT prolongation, he added. Ultimately, new formulations of TKIs like the oral tablet formulation of nilotinib make receiving TKIs easier for patients with CML, Mauro concluded.