CAMBRIDGE, UK, June 2, 2026
Cycle Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved CAVHANZA™ (nilotinib) Orally Disintegrating Tablets, a novel treatment option for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Developed in collaboration with Flex Pharma, the newly approved formulation is designed to improve nilotinib solubility and dissolution, enabling patients to use proton pump inhibitors (PPIs) and H₂ receptor antagonists (H₂RAs) without timing restrictions while maintaining bioavailability. The approval introduces the first orally disintegrating nilotinib formulation to the market and expands treatment flexibility for patients living with chronic leukemia
New Option Addresses Long-Standing Treatment Challenges
CAVHANZA addresses a significant challenge in the management of Ph+ CML, where many patients require acid-reducing medications that can interfere with the absorption and effectiveness of conventional nilotinib therapies. The new formulation was specifically engineered to overcome this limitation while preserving the proven efficacy of the second-generation tyrosine kinase inhibitor. Clinical data also demonstrated that CAVHANZA has no food effect, allowing patients to take the therapy without regard to meals. This added convenience may reduce treatment burden, simplify dosing schedules, and support improved adherence among patients undergoing long-term therapy.
Flex Pharma Technology Enhances Drug Delivery
The approval highlights the strategic partnership between Cycle Pharmaceuticals and Flex Pharma, which utilized its proprietary ElectroNanoSpray™ (ENS) technology platform to develop an improved formulation of nilotinib. The technology enhances drug dissolution and absorption characteristics while retaining the established clinical benefits of the active ingredient. In addition to offering compatibility with acid-reducing therapies, the orally disintegrating tablet can be taken with or without water, providing an alternative for patients who experience swallowing difficulties. Company leaders stated that the collaboration demonstrates how advanced drug delivery technologies can improve patient experience without altering the underlying therapeutic mechanism.
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Expanding Treatment Access for Ph+ CML Patients
CAVHANZA is approved for adults with newly diagnosed Ph+ CML in chronic phase, as well as adults with chronic-phase or accelerated-phase disease who are resistant or intolerant to prior therapies, including imatinib. The product represents the second oncology therapy in Cycle Pharmaceuticals’ growing cancer portfolio and the company’s tenth commercial product overall. Supported by the Cycle Vita™ patient assistance program, the upcoming launch is expected to provide patients with additional access resources and treatment guidance. With the FDA approval secured, Cycle Pharmaceuticals and Flex Pharma aim to deliver a differentiated therapy that addresses practical treatment barriers while expanding options for patients with rare leukemia
Source: Cycle Pharmaceuticals press release
