FDA Approves Danziten for Chronic Myeloid Leukemia Without Mealtime Restrictions

The FDA has granted approval to Azurity Pharmaceuticals' nilotinib tablets (Danziten) for chronic myeloid leukemia (CML), making this version of the tyrosine kinase inhibitor (TKI) the only one that can be taken without mealtime restrictions. Danziten is indicated for adult patients newly diagnosed with Philadelphia chromosome-positive CML in chronic phase and for those with chronic- or acute-phase disease resistant or intolerant to previous treatments that included imatinib.

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The announcement from Azurity Pharmaceuticals stated that patients with CML do not need to abstain from food with this treatment as it "offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna," according to Richard Blackburn, CEO.

When taken with food, Tasigna, the original formulation, can prompt excess absorption, raising the risk of prolonged QT intervals on electrocardiogram, a potential cardiotoxicity that could result in serious cardiac events. Danziten’s formulation removes the need for rigid mealtime adherence.

The therapy's enhanced formula offers comparable efficacy to Tasigna, with consistent pharmacokinetics and bioavailability, even in the absence of fasting. The drug provides a lower-dose option while maintaining efficacy, potentially improving patient adherence—a critical factor in managing CML.

Studies have shown that optimal TKI therapy, such as nilotinib, can help some patients achieve deep molecular responses and treatment-free remission, according to the statement. Additionally, with appropriate treatment, newly diagnosed patients with chronic-phase CML can approach a life expectancy comparable with that of the general population.

To facilitate patient access, Azurity stated that it will offer Danziten through a network that includes Biologics by McKesson and a limited specialty distribution. The company has also established DanzitenCONNECT, a patient support program that provides prior authorization and benefits investigation, a free initial month of therapy, potential copay reductions to as low as $0, and assistance through a patient assistance program.

Reference

Azurity Pharmaceuticals, Inc, announces FDA approval of Danziten (nilotinib) tables, the first and only nilotibin with no mealtime restrictions. News release. Azurity Pharmaceuticals. November 14, 2024. Accessed November 14, 2024. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-danziten-nilotinib-tablets-the-first-and-only-nilotinib-with-no-mealtime-restrictions/