Danziten FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 17, 2024.

FDA Approved: Yes (First approved November 7, 2024)
Brand name: Danziten
Generic name: nilotinib tartrate
Dosage form: Tablets
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia

Danziten (nilotinib tartrate) is a kinase inhibitor used for the treatment of Philadelphia chromosome positive chronic myeloid leukemia.

• Danziten is indicated for the treatment of:
  - adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
  - adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
• Nilotinib was first approved in 2007 under the brand name Tasigna (nilotinib monohydrochloride monohydrate). Tasigna has variable bioavailability which increases considerably when taken with food, potentially prolonging the QT interval. Strict fasting is therefore crucial with Tasigna to avoid cardiotoxicity, and the Boxed Warning on the product label includes a statement to avoid food two hours before and one hour after taking each dose.
• Danziten is a re-engineered formulation of nilotinib that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose. Unlike Tasigna, Danziten can be taken without mealtime restrictions, and has the potential to improve patients adherence due to the removal of fasting requirements.
• Danziten tablets are taken orally, twice daily. Danziten has different strengths and dosages compared to Tasigna and may not be substitutable with Tasigna on a milligram per milligram basis.
• The Danziten product label includes a Boxed Warning for QT interval prolongation and sudden death. Warnings and precautions include substitution with other nilotinib products and risk of medication errors, myelosuppression, cardiac and arterial vascular occlusive events, pancreatitis and elevated serum lipase, hepatotoxicity, electrolyte abnormalities, tumor lysis syndrome, hemorrhage, fluid retention, and embryo-fetal toxicity.
• Common adverse reactions (≥ 20%) include nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.
  Common hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia, and anemia. 

Development timeline for Danziten

Further information

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