FDA Approves Danziten: A Breakthrough Nilotinib Treatment for Chronic Myeloid Leukemia Without Mealtime Restrictions

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Danziten (nilotinib) tablets, developed by Azurity Pharmaceuticals, for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase and those with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib12.

No Mealtime Restrictions:
Unlike Tasigna, the original formulation of nilotinib, Danziten does not require patients to fast before or after taking the medication, offering greater convenience and potentially improving adherence13.

Equivalent Efficacy:
Danziten has demonstrated equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose and consistent pharmacokinetics regardless of fasting state or meal type13.

Availability:
Danziten will be available through Biologics by McKesson and Limited Specialty Distribution, with additional patient support provided through DanzitenCONNECT, a comprehensive program offering prior authorization support, benefits investigation, a free first month of Danziten, and a co-pay of as little as $015.

Clinical Significance:
The approval of Danziten addresses a significant challenge in CML treatment by removing mealtime restrictions, which can lead to better patient adherence and outcomes. Optimal tyrosine kinase inhibitor (TKI) therapy, such as nilotinib, can help patients achieve deep molecular responses and, in some cases, treatment-free remission15.

Sources:

1. https://www.prnewswire.com/news-releases/azurity-pharmaceuticals-inc-announces-fda-approval-of-danziten-nilotinib-tablets-the-first-and-only-nilotinib-with-no-mealtime-restrictions-302306329.html

2. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-danziten-nilotinib-tablets-the-first-and-only-nilotinib-with-no-mealtime-restrictions/

3. https://www.onclive.com/view/fda-approves-nilotinib-tablets-without-mealtime-restrictions-for-cml

5. https://www.ajmc.com/view/fda-approves-danziten-for-chronic-myeloid-leukemia-without-mealtime-restrictions