Cycle Pharmaceuticals launches CAVHANZA™ (nilotinib) Orally Disintegrating Tablets (ODT), designed for use with PPIs and H₂RAs without food restrictions1

CAMBRIDGE, England, August 24, 2026--Cycle Pharmaceuticals (Cycle) announces the launch of CAVHANZA in the United States, offering greater dosing flexibility and potential tolerability benefits for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), while maintaining established efficacy at a 60% lower milligram strength than Tasigna® (nilotinib).2

Made in partnership with Flex Pharma (Flex), CAVHANZA offers a distinct option within the nilotinib landscape. Administrable alongside proton pump inhibitors (PPIs) and/or H₂ receptor antagonists (H₂RAs) with no timing restrictions, the new treatment addresses a known clinical challenge, where approximately 47% of patients with Ph+ CML may also require acid-reducing agents such as PPIs that may compromise treatment bioavailability.1,3

In addition, as the first FDA-approved ODT formulation of nilotinib, CAVHANZA offers simplified administration: tablets can be taken with or without food or water, providing flexibility for patients and supporting adherence to therapy.1,4

Jamie Ray, Vice President - Patient Support Programs shared, "At Cycle, we're focused on helping treatment fit more seamlessly into patients' everyday lives. CAVHANZA offers meaningful flexibility – through PPI compatibility and fewer dietary restrictions – that may help reduce the day-to-day burden of treatment. Through Cycle Vita™, our dedicated patient support* program, we're committed to providing the guidance, resources, and continuity of care patients need throughout their treatment journey."

Cycle has been delivering patient-focused treatments since 2017. The launch of CAVHANZA represents the 10th product in Cycle's portfolio and the 2nd product to enhance treatment options for patients living with Ph+ CML.

Learn more about CAVHANZA at https://cavhanza.com/.

Warning: QT Prolongation and Sudden Deaths

Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments.

Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome.

Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors.

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).