FDA approval for Danziten (nilotinib) to treat Philadelphia chromosome positive chronic myeloid leukemia – Azurity Pharma

Azurity Pharmaceuticals announced that the FDA has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib.

“Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna,” said Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc. “Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions.”

Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP. However, Tasigna has variable bioavailability that considerably increases when taken with food. In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity.

Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose. Danziten demonstrates consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib. With optimal tyrosine kinase inhibitor (TKI) therapy, patients can achieve deep molecular responses, and some may even attain treatment-free remission. The life expectancy of newly diagnosed CP-CML patients who have responded to appropriate treatment is now approaching that of the general population. However, challenges remain, including patient adherence to treatment. Danziten has the potential to improve adherence due to the removal of fasting requirements.

Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution.

Azurity will offer patient support through DanzitenCONNECT, a comprehensive program, subject to terms and conditions, that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay of as little as $0, and a Patient Assistance Program (PAP).