The FDA has granted approval to nilotinib tablets, marketed as Danziten, for adult patients with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) in chronic phase (CP-CML). This approval extends to both newly diagnosed patients and those with CP- and acute phase (AP)-CML who have shown resistance or intolerance to prior therapy, including imatinib.
This approval marks a significant advancement as Danziten does not require mealtime restrictions, unlike the original formulation of nilotinib (Tasigna). Tasigna, initially approved in 2007, necessitated patients to avoid food for two hours before and one hour after administration due to bioavailability concerns.
Advantages of Danziten
Richard Blackburn, CEO of Azurity Pharmaceuticals, highlighted that Danziten offers equivalent efficacy to Tasigna without the burden of fasting requirements. The re-engineered formulation of nilotinib in Danziten improves bioavailability, enabling a lower dose and eliminating mealtime restrictions without compromising efficacy.
Danziten has demonstrated consistent pharmacokinetics without clinically significant differences in nilotinib exposure, irrespective of fasting state or meal type. This eliminates the risk of prolonged QT intervals associated with Tasigna when taken with food.
Clinical Trial Data
The approval of Tasigna was supported by the phase 3 ENESTnd (NCT00471497) trial in newly diagnosed Ph-positive CP-CML and the phase 1/2 Study A2101 (NCT00109707) in pretreated CP- or AP-CML. These trials are referenced in the prescribing information for Danziten.
Data from ENESTnd revealed that patients treated with nilotinib (n = 282) achieved a 12-month major molecular response (MMR) rate of 44% (95% CI, 38.4%-50.3%) compared to 22% (95% CI, 17.6%-27.6%) for those receiving imatinib (n = 283; P < .0001). At 60 months, 77% of patients in the nilotinib arm achieved a MMR vs 60% in the imatinib arm.
Study A2101, a single-arm trial, demonstrated that nilotinib elicited an unconfirmed major cytogenetic response (MCyR) rate of 51% (95% CI, 46%-57%) in patients with resistant or intolerant Ph-positive CP- or AP-CML (n = 321).
