FDA Approves an Orally Disintegrating Nilotinib Formulation for Patients With Ph-Positive Chronic Myeloid Leukemia
The US Food and Drug Administration (FDA) has approved an orally disintegrating tablet formulation of nilotinib (CAVHANZA™; Cycle Pharmaceuticals) for adult patients with newly diagnosed chronic-phase Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML), as well as for adult patients with chronic-phase or accelerated-phase Ph-positive CML who are resistant or intolerant to prior therapy.
The formulation was developed in collaboration with Flex Pharma using its ElectroNanoSpray platform to reformulate nilotinib while maintaining established efficacy. It was specifically designed to improve solubility and dissolution, allowing concomitant administration with proton pump inhibitors and H2 receptor antagonists without timing restrictions. The product can also be taken without regard to meals and may offer an alternative for patients who have difficulty swallowing tablets.
“Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey,” said Victoria Dickinson, chief product officer at Cycle Pharmaceuticals. “Bringing another option to market is an exciting prospect.”
The recommended dosing and indications are consistent with approved nilotinib use in adults with Ph-positive CML and is not approved for pediatric patients.
The most frequently reported adverse reactions included rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea, vomiting, thrombocytopenia, neutropenia, and anemia.
The prescribing information includes a boxed warning for QT prolongation and sudden death. Additional warnings and precautions include myelosuppression, cardiovascular and arterial occlusive events, pancreatitis, hepatotoxicity, electrolyte abnormalities, tumor lysis syndrome, hemorrhage, fluid retention, and embryo-fetal toxicity.
Source:
Cycle Pharmaceuticals. CAVHANZA™ (nilotinib) orally disintegrating tablets: A new, FDA-approved treatment. Accessed on June 11, 2026. https://cyclepharma.com/news/cavhanza-nilotinib-orally-disintegrating-tablets-fda-approval/
