WASHINGTON, June 4, 2026 - The U.S. Food and Drug Administration (FDA) has approved a new form of nilotinib (Cavhanza™) for use in adults with Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML).
This new version is an oral, dissolvable tablet that can be taken with or without food, can be taken without water, and does not include any restrictions related to when the patient last took acid reducing medications.
This new formulation addresses a common and longstanding challenge in CML care, as many patients rely on medications that can interfere with the body’s ability to absorb some standard CML oral therapies. The dissolvable format may also benefit individuals who have difficulty swallowing pills, offering greater flexibility and ease of use.
“Treatment that is easier to take and better aligned with patients’ daily lives is extremely meaningful,” said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United. “Advances like this can make a real difference in quality of life and a patient’s ability to stay on therapy over the long term.”
While nilotinib has been an established therapy for Ph+ CML for many years, this newly approved formulation represents an important step forward in patient‑centered drug design, aiming to reduce treatment burden while maintaining effectiveness.
Decades of Progress in CML
Advances in the treatment of CML have profoundly been shaped by foundational research funded by Blood Cancer United. Early investments in the science behind targeted therapies — including work that helped pave the way for the first targeted treatment, imatinib (Gleevec) — transformed CML from a once fatal disease into a manageable condition for many patients.
“Blood Cancer United remains committed to investing in innovative research that not only advances cures but also continues to improve care to be more patient-friendly,” Dr. Gruenbaum concluded.
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