FDA Approves Orally Disintegrating Nilotinib Tablets for Chronic Myeloid Leukemia

The FDA has approved an orally disintegrating tablet formulation of nilotinib (Cavhanza) for the treatment of select patients with chronic myeloid leukemia (CML), with the formulation designed to maintain bioavailability and enable concomitant use of acid-reducing agents, such as proton pump inhibitors and/or H₂ antagonists, without timing restrictions.¹

Specifically, this formulation of nilotinib is indicated for:

• Adult patients with newly diagnosed Philadelphia chromosome (Ph)–positive CML in chronic phase
• Adult patients with chronic and accelerated phase Ph-positive CML with resistance or intolerance to prior therapy, including imatinib (Gleevec)

“It’s always a good day for patients when we see yet another option [approved],” Michael J. Mauro, MD, told OncLive^®. “When a patient needs an alternate formulation, we need to probably not focus on necessarily cost, access, and all the things that we think about when we feel like there’s a menu of drugs and we have to find the best fit for our purpose. But if a patient has an unavoidable drug interaction or a real challenge in adherence, which is limiting their ability to get in remission or to have a maximum best quality of life, these kinds of approvals are really going to allow us to have more flexibility to tailor the treatments to our patients who have certain comorbidities and health challenges. I’m really delighted to see this kind of research develop for our patients with CML moving forward.”

Mauro is an attending physician at Memorial Sloan Kettering Cancer Center in New York, New York.

“We’re excited to be able to offer the CML community another TKI option that may better suit their needs,” Victoria Dickinson, chief product officer at Cycle Pharma, stated in a news release. “Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey. Bringing another option to market—backed by Cycle Vita, our dedicated patient support program—is an exciting prospect for Cycle.”

Why can the orally disintegrating tablet formulation of nilotinib be taken with concomitant acid-reducing agents?

The prescribing information for nilotinib (Tasigna), the initial formulation of the agent approved by the FDA, recommends that patients fast for at least 2 hours prior to and at least 1 hour after dosing.² The Tasinga prescribing information also recommends the avoidance of proton pump inhibitors during treatment. H₂ blockers or antacids are recommended as alternatives to proton pump inhibitors; however, it is recommended that H₂ blockers not be used for approximately 10 hours prior to dosing and approximately 2 hours after dosing, and antacid use is not recommended 2 hours before or after dosing.

According to Cycle Pharma, clinical studies of Cavhanza showed that the agent demonstrated no food effect, allowing it to be taken without regard to food, which could permit more flexible dosing and improve treatment efficacy.¹

Cavhanza carries warnings for QT prolongation and sudden death. It is recommended to monitor for hypokalemia or hypomagnesemia and correct deficiencies. ECGs should be obtained at baseline, on day 7, and periodically following the start of treatment, and following any dose adjustments, to monitor QTc.

Due to the risk for sudden deaths, Cavhanza should not be given to patients with hypokalemia, hypomagnesemia, or long QT syndrome. Concomitant use of QT-prolonging drugs and strong CYP3A4 inhibitors should also be avoided.

What is the recommended dosing for the orally disintegrating tablet formulation of nilotinib?

The prescribing information for this formulation of nilotinib notes that the agent may have different strengths and dosages compared with other nilotinib products and may not be substitutable with other products on a mg-per-mg basis.³

For patients with newly diagnosed, Ph-positive CML in chronic phase, the orally disintegrating tablet is recommended at 120 mg twice per day. For patients with resistant or intolerant Ph-positive CML in chronic phase or accelerated phase, the agent is recommended at 160 mg twice per day.

References

1. Cavhanza (nilotinib) orally disintegrating tablets: a new, FDA-approved treatment. News release. Cycle Pharma. June 2, 2026. Accessed June 2, 2026. https://cyclepharma.com/news/cavhanza-nilotinib-orally-disintegrating-tablets-fda-approval/
2. Tasigna. Prescribing information. Updated February 2024. Accessed June 2, 2026. https://www.novartis.com/us-en/sites/novartis_us/files/tasigna.pdf
3. Cavhanza. Prescribing information. May 2026. Accessed June 2, 2026. https://cyclepharma.com/wp-content/uploads/2026/06/FPI-0045-USPI-Approved.pdf