Azurity Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Danziten (nilotinib) tablets for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, and for patients with chronic phase (CP) or accelerated phase (AP) CML who are resistant or intolerant to prior therapies, including imatinib. Danziten distinguishes itself as the first and only nilotinib formulation that does not require mealtime restrictions.
Richard Blackburn, CEO of Azurity Pharmaceuticals, Inc., stated, "Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna. 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."
Overcoming Treatment Challenges in CML
Tasigna, another nilotinib formulation, has proven efficacy in treating Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP. However, its bioavailability is significantly affected by food intake, potentially leading to cardiotoxicity if taken without adhering to strict fasting guidelines. This necessitates careful management to avoid QT interval prolongation, a known risk associated with nilotinib when taken with food.
Danziten addresses this challenge through a re-engineered formulation of nilotinib that eliminates the need for mealtime restrictions. This improved bioavailability allows for a lower dose while maintaining equivalent efficacy to Tasigna. Clinical data indicates consistent pharmacokinetics for Danziten, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type. This offers the proven efficacy of nilotinib without the burden of dietary restrictions, potentially improving patient adherence and quality of life.
Impact on CML Treatment and Adherence
Optimal tyrosine kinase inhibitor (TKI) therapy, like nilotinib, can lead to deep molecular responses and potentially treatment-free remission for CML patients. With effective treatment, the life expectancy of newly diagnosed CP-CML patients can approach that of the general population. However, adherence to treatment remains a significant challenge. The removal of fasting requirements with Danziten has the potential to improve adherence, as highlighted by Leukemia & Lymphoma Society.
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 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).
