FDA Approves Nilotinib With No Mealtime Restrictions in Ph-Positive CML
The FDA has approved a re-engineered formulation of nilotinib with no mealtime restrictions for adult patients with newly diagnosed Ph-positive CP- and AP-CML, or for those resistant or intolerant to prior therapy, including imatinib.
- The FDA granted approval to nilotinib (Danziten) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP).
- This indication is intended for patients who are resistant or intolerant to prior therapy that included imatinib (Gleevec).
- This marks the first and only approval of nilotinib that has no mealtime restrictions.
The first indication of nilotinib tablets with no mealtime restrictions has been approved by the FDA for treating adult patients with newly diagnosed Ph–positive CP- and AP-CML that is resistant or intolerant to prior therapy that included imatinib.1
Unlike standard nilotinib (Tasigna), approved by the FDA for this patient population in 2007 and in 2010 for adult patients with newly diagnosed Ph-positive CP-CML2, this nilotinib formulation offers no mealtime restrictions and a lower dose.
Nilotinib tablets are a re-engineered formulation of nilotinib that has improved bioavailability. The tablets have shown improved pharmacokinetics with consistent nilotinib exposure, regardless of fasting state or meal type.1
“Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna,” said Richard Blackburn, chief executive officer of Azurity Pharmaceuticals, in a press release. “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.”
3D rendering of leukemia cells in blood flow
According to the prescribing information, patients on Tasigna must avoid food for 2 hours before and 1 hour after treatment due to its variable bioavailability, which increases when taken with food. This increased bioavailability can significantly prolong the QT interval, noted Azurity Pharmaceuticals, the developer of the nilotinib tablets.2
The prescribing information for the nilotinib tablets showed that the kinase inhibitor is indicated for the treatment of adult patients with newly diagnosed Ph-positive CP- or AP-CML resistant to or intolerant to prior therapy that included imatinib.3 The recommended dose for newly diagnosed patients with Ph-positive CML-CP is 142 mg orally twice daily. For those resistant or intolerant with Ph-positive CML-CP and CML-AP, the dose set is 190 mg orally twice daily.
The starting dose should be reduced in patients with baseline hepatic impairment. Additionally, newly diagnosed adult patients with Ph-positive CML-CP who have received nilotinib tablets for at least 3 years and achieved a sustained molecular response, as well as those with Ph-positive CML-CP resistant or intolerant to imatinib meeting the same criteria, may be eligible for treatment discontinuation.
REFERENCES
Azurity Pharmaceuticals, Inc. announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions. News release. Azurity Pharmaceuticals. November 14, 2024. Accessed November 15, 2024. https://tinyurl.com/m3ntv5s5
Tasigna. Novartis. Updated June 2010. Accessed November 15, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf
Danziten. Azurity Pharmaceuticals. November 2024. Accessed November 15, 2024. https://danziten.com/wp-content/uploads/2024/11/Danziten-Prescribing-Information.pdf
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