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

“Any [treatment] intolerance can compromise [the efficacy of the treatment]. In reality, we see more intolerance than resistance with TKIs…Having a new approval for a drug with better tolerance is always a good thing.”

Elias Jabbour, MD, a professor of leukemia at The University of Texas MD Anderson Cancer Center, discussed the significance of the June 2026 FDA approval of the orally disintegrating tablet for nilotinib (Cavhanza), and how the regulatory decision introduces a well-tolerated option amongst the abundance of TKIs in the chronic myeloid leukemia (CML) treatment paradigm.

This formulation of nilotinib was approved for the treatment of adult patients with newly diagnosed Philadelphia (Ph) chromosome–positive CML in chronic phase; and adult patients with chronic or accelerated phase Ph-positive CML with resistance to intolerance to prior therapy, including imatinib (Gleevec). Notably, the prescribing information for the formulation suggests twice daily 120 mg doses for patients with newly diagnosed, chronic phase, Ph-positive CML, and 160 mg twice per day for those with resistant or intolerant Ph-positive CML in chronic phase or accelerated phase.

Jabbour began by asserting that more available TKIs in clinic equates to more options for patients with CML. Despite the abundance of treatment options for this patient population, Jabbour noted that to achieve the goal of improved survival and treatment-free remissions, treatments must be well tolerated by patients. Any intolerance to TKIs can compromise their effectiveness, and intolerance to TKIs is more common than resistance, he added. Therefore, an approval for a treatment such as this nilotinib formulation, which enables the concomitant use of acid-reducing agents without timing restrictions, is always positive for patients and the CML treatment paradigm, Jabbour said.

Jabbour also explained methods for approaching CML treatment selection when considering different TKIs and varying formulations, which can help to better personalize treatment in clinical practice. The individual profile of each patient is crucial to personalizing CML treatment, and an increased number of options helps clinicians select options that better fit those patient profiles, he underscored.