Cavhanza Approved by the FDA to Treat Adults With Ph+ CML

Key Takeaways:

• Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has recently approved the use of Cavhanza (nilotinib) in treating patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
• Nilotinib addresses a common issue in Ph+ CML therapies in which one-fourth of patients are prescribed additional medications that reduce the treatment’s overall efficacy.
• Nilotinib could improve treatment outcomes as its lack of food restrictions and easy ingestion increases dosing flexibility.

On June 2, 2026, Cycle Pharmaceuticals announced that nilotinib oral tablets received FDA approval for treating adults with Ph+ CML. It is Cycle’s tenth product and the second created to improve treatment for Ph+ CML.

This medication is a tyrosine kinase inhibitor (TKI) specifically designed to improve solubility and enhance bioavailability.

Twenty-five percent of patients with Ph+ CML are also prescribed proton pump inhibitors (PPIs) or H₂ antagonists (H₂RAs), which can compromise treatment effectiveness. Nilotinib can be used in combination with these therapies without impacting overall efficacy.

Furthermore, nilotinib reduces dosing requirements, which could improve patient outcomes. Unlike other TKIs, nilotinib does not have any food restrictions, which is a major care burden that leads to interruption or discontinuation of treatment. The tablets also disintegrate when taken orally, allowing easy dosing for patients with difficulty swallowing.

Victoria Dickinson, chief product officer at Cycle Pharma, said, “We’re excited to be able to offer the CML community another 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.”

The FDA approval expands treatment options for adults with Ph+ CML and introduces a TKI formulation designed to address practical challenges that may affect treatment adherence.

Reference

CAVHANZA™ (nilotinib) orally disintegrating tablets: a new, FDA-approved treatment. Cycle Pharma. Published June 2, 2026. Accessed July 20, 2026. https://cyclepharma.com/news/cavhanza-nilotinib-orally-disintegrating-tablets-fda-approval/