FDA OKs Oral Nilotinib Tablets in Ph+ Chronic Myeloid Leukemia

The FDA has approved an oral disintegrating tablet formulation of nilotinib (Cavhanza) for adults with newly diagnosed Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase and accelerated phase Ph-positive CML with resistance or intolerance of prior therapy including imatinib (Gleevec), according to a press release from the developer, Cycle Pharmaceuticals.

Developers designed the tablet formulation of nilotinib to improve solubility and dissolution rates, making the agent more compatible with acid-reducing agents like proton pump inhibitors and/or H₂ antagonists without timing restrictions. Prior data showed that nilotinib tablets produced no food effect, allowing patients to receive more flexible dosing of treatment without regard to meals or other food-related burdens. Additionally, the formulation may support patients who experience difficulty with swallowing and enable them to take treatment with or without water.

“We’re excited to be able to offer the CML community another tyrosine kinase inhibitor [TKI] option that may better suit their needs. Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey,” Victoria Dickinson, chief product officer at Cycle Pharmaceuticals, said in the press release.

The prescribing label for the nilotinib tablets includes a warning for QT prolongation and sudden deaths. Patients are advised to avoid concomitant use of drugs like QT-prolonging agents and strong strong CYP3A4 inhibitors.

“Leveraging our proprietary ElectroNanoSpray™ platform, we reformulate established oncology molecules to enhance bioavailability and optimize dosing performance. Together with Cycle’s rare-disease commercialization expertise, we aim to efficiently deliver improved treatment options for patients with rare leukemias,” Christian Wertz, PhD, President of Flex Pharma, stated in the press release.

Reference

CAVHANZA™ (nilotinib) orally disintegrating tablets: a new, FDA-approved treatment. News release. Cycle Pharmaceuticals. June 2, 2026. Accessed June 2, 2026. https://tinyurl.com/3j62e728