FDA approves Danziten, the first nilotinib treatment for Ph+ CML with no mealtime restrictions

Azurity Pharmaceuticals has announced a breakthrough in the treatment landscape for chronic myeloid leukemia (CML). The FDA has approved Danziten™, the first and only nilotinib formulation that removes the strict fasting requirements traditionally required with similar therapies. This new medication offers adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) and those with chronic or acute phase (CP or AP) CML who are resistant or intolerant to previous therapies, including imatinib, a more flexible and potentially adherence-friendly treatment option.

"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."

How Danziten Differs from Tasigna
Novartis' Tasigna, a well-known therapy for Ph+ CML, requires strict fasting to prevent potential side effects, particularly the risk of QT interval prolongation—a heart rhythm issue that can lead to serious complications if Tasigna is taken with food. 

Danziten offers consistent pharmacokinetics, meaning that nilotinib exposure levels remain stable whether or not the patient has eaten. This feature not only reduces the risk of complications but also allows for a lower dosage, providing equivalent efficacy to Tasigna with fewer restrictions. By removing mealtime limitations, Danziten may encourage better adherence, an important factor in achieving optimal treatment outcomes in CML patients.

Proven Efficacy, Greater Flexibility
The efficacy of nilotinib as a tyrosine kinase inhibitor (TKI) has been well established, and effective TKI therapy can help CML patients achieve deep molecular responses, and in some cases, treatment-free remission. The improved ease of administration and potential for enhanced adherence may support these patients in achieving durable responses.

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