FDA

FDA approves nilotinib formulation without mealtime restrictions

November 20, 2024

Brand name: Danziten

Generic name: nilotinib

Manufacturer: Azurity Pharmaceuticals

Approval date: November 14, 2024

FDA approved Danziten, a nilotinib formulation with no mealtime restrictions, for the treatment of adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adults with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.

Tasigna (nilotinib) has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP. However, owing to Tasigna’s variable bioavailability that considerably increases when taken with food, it may significantly prolong QT interval when inappropriately taken with a meal. Thus, strict fasting with Tasigna is required to avoid cardiotoxicity.

According to a manufacturer press release, Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that has 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.

Efficacy

The effectiveness of 142 mg twice daily of Danziten for the treatment of adults with newly diagnosed Ph+ CML-CP was established from Tasigna’s phase 3 ENESTnd trial (NCT00471497).

The effectiveness of 190 mg twice daily of Danziten for the treatment of adults with Ph+ CML- CP and Ph+ CML-AP resistant or intolerant to prior therapy that included imatinib was established from Tasigna’s phase 1/2 A2101 trial (NCT00109707).

Safety

The most commonly reported non-hematologic adverse reactions are nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats and for hematologic adverse reactions, myelosuppression, thrombocytopenia, neutropenia, and anemia.

Recommended dose

Recommended adult doses of Danziten are as follows:

• Newly diagnosed Ph+ CML-CP: 142 mg PO bid
• Resistant or intolerant Ph+ CML-CP and CML-AP: 190 mg PO bid

Source:

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

Azurity Pharmaceuticals: Danziten (nilotinib) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219293s000lbl.pdf