News|Articles|June 2, 2026

FDA Approves Cavhanza for PH-positive Chronic Myeloid Leukemia

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Key Takeaways

Indications include newly diagnosed chronic-phase Ph+ CML and chronic/accelerated-phase disease after resistance or intolerance to prior therapy, including imatinib.
Concomitant use with PPIs and H₂RAs is permitted without special timing, addressing a frequent real-world co-medication that can impair nilotinib absorption.
Administration is flexible relative to food, and the orally disintegrating format supports patients unable to swallow tablets, with or without water.
Boxed warning highlights QT prolongation and sudden deaths; avoid in hypokalemia, hypomagnesemia, or congenital long QT, and perform baseline/on-treatment ECG monitoring.
Additional risks include cytopenias, arterial occlusive events, pancreatitis, hepatotoxicity, tumor lysis syndrome, serious bleeding, fluid retention, teratogenicity, and clinically relevant drug–drug interactions.

FDA approved Cavhanza, a new nilotinib formulation for adults with Ph+ CML that may offer more flexible dosing and easier administration.

The FDA has approved Cavhanza (nilotinib), a new orally disintegrating tablet formulation for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), according to an announcement from Cycle Pharmaceuticals.

Cavhanza is approved for adults with newly diagnosed chronic-phase Ph+ CML, as well as adults with chronic-phase or accelerated-phase Ph+ CML whose disease is resistant to or intolerant of prior treatment, including Gleevec (imatinib).

According to the company, Cavhanza was designed to address several challenges associated with treatment with nilotinib. Unlike currently available formulations, Cavhanza can be taken with proton pump inhibitors (PPIs) and H₂ receptor antagonists (H₂RAs), medications commonly used to reduce stomach acid, without requiring special timing between doses.

Researchers noted that approximately 25% of patients receiving nilotinib are also prescribed acid-reducing medications, which can interfere with how the drug is absorbed by the body.

Clinical testing showed that Cavhanza can be taken without regard to meals. This may reduce treatment burden for patients, as some cancer therapies require strict scheduling around food intake. The orally disintegrating tablet also may benefit patients who have difficulty swallowing pills because it can dissolve in the mouth and may be taken with or without water.

"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 Pharmaceuticals, said in the announcement.

Tyrosine kinase inhibitors (TKIs) are targeted therapies that block proteins that help cancer cells grow and survive. Nilotinib is a second-generation TKI that has been used to treat Ph+ CML for many years.

Cycle Pharmaceuticals stated that the new formulation was developed in partnership with Flex Pharma using technology designed to improve how the medication dissolves and is absorbed.

Safety Information

Cavhanza carries a boxed warning for QT prolongation, a change in the heart's electrical activity that can lead to serious or potentially life-threatening heart rhythm problems. Sudden deaths have been reported in patients receiving nilotinib.

The drug should not be used in patients with low potassium levels, low magnesium levels or long QT syndrome. Doctors are advised to monitor heart rhythm with electrocardiograms (ECGs) before and during treatment.

Other important risks associated with Cavhanza include:

Low blood cell counts, including low platelets, low neutrophils and anemia.
Cardiovascular and arterial events.
Pancreatitis, or inflammation of the pancreas.
Liver toxicity.
Tumor lysis syndrome, a potentially serious complication that can occur when cancer cells break down rapidly.
Serious bleeding events.
Fluid retention.
Harm to an unborn baby if used during pregnancy.

Common side effects reported with nilotinib include rash, itching, headache, nausea, fatigue, hair loss, muscle pain, abdominal pain, constipation, diarrhea and vomiting.

Patients are advised to discuss all medications they take with their healthcare team because certain drugs, including medications that affect heart rhythm and some medications that affect liver enzymes, may interact with Cavhanza.

Cycle Pharmaceuticals announced that Cavhanza is expected to launch soon in the United States.