FDA Approves Danziten (nilotinib) for Adult Patients with Newly Diagnosed or Resistant/Intolerant Ph+ CML

Not reported in label.

Danziten is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. It is also indicated for adult patients with chronic phase and accelerated phase Ph+ CML resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna (nilotinib) capsules but is not labeled for Danziten due to marketing exclusivity rights.

The recommended dosage for adult patients with newly diagnosed Ph+ CML-CP is 142 mg orally twice daily at approximately 12-hour intervals with or without food. For adult patients with resistant or intolerant Ph+ CML-CP and CML-AP, the recommended dosage is 190 mg orally twice daily at approximately 12-hour intervals with or without food. Patients should swallow tablets whole with water and not cut, crush, or chew them. If a dose is missed, take the next scheduled dose at its regular time; do not take two doses at once. The starting dose should be reduced in patients with baseline hepatic impairment. Danziten may not be substitutable with other nilotinib products on a milligram per milligram basis; use Table 1 for switching between Danziten and Tasigna based on dosage equivalence. Eligible newly diagnosed adult patients with Ph+ CML-CP who have received Danziten for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received Danziten for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.

trial data not available in label

Not reported in label.

Danziten is a kinase inhibitor used for Ph+ CML in specified adult populations. It may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated, or with hydroxyurea or anagrelide if clinically indicated. Treatment discontinuation may be considered for eligible patients after sustained molecular response, with monitoring for possible loss of remission.