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FDA Approves Danziten (Nilotinib) Tablets with No Mealtime Restrictions for CML

• The FDA has approved Danziten (nilotinib) for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), offering a new treatment option. • Danziten is a re-engineered formulation of nilotinib with improved bioavailability, allowing for a lower dose and consumption without mealtime restrictions. • Clinical trials supporting the approval demonstrated significant major molecular response rates compared to imatinib in newly diagnosed patients. • Danziten provides an alternative to Tasigna, eliminating the need for fasting, which simplifies medication management for CML patients.

The FDA has granted approval to Danziten (nilotinib) tablets, offering a new treatment option without mealtime restrictions for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), as well as for those with CP- and acute phase (AP)-CML resistant or intolerant to prior therapies, including imatinib.
This approval marks a significant advancement in CML treatment, addressing a key challenge associated with the original nilotinib formulation (Tasigna), which required strict fasting conditions. Richard Blackburn, CEO of Azurity Pharmaceuticals, stated that Danziten offers equivalent efficacy to Tasigna but liberates CML patients from mealtime restrictions, enhancing their quality of life.

Clinical Efficacy and Bioavailability

Danziten's approval is supported by data from the Phase 3 ENESTnd trial (NCT00471497) and the Phase 1/2 Study A2101 (NCT00109707), which were pivotal in the initial approval of Tasigna. These trials demonstrated the efficacy of nilotinib in both newly diagnosed and pretreated CML patients. The re-engineered formulation of Danziten improves bioavailability, allowing for a lower dose without compromising efficacy, and eliminates the need for fasting.

ENESTnd Trial Results

Data from ENESTnd showed that patients treated with nilotinib (n = 282) experienced a 12-month major molecular response (MMR) rate of 44% (95% CI, 38.4%-50.3%) compared with 22% (95% CI, 17.6%-27.6%) for those given imatinib (n = 283; P < .0001). At 60 months, 77% of patients in the nilotinib arm achieved a MRR vs 60% of patients in the imatinib arm, highlighting the sustained efficacy of nilotinib.

Study A2101 Results

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). The confirmed hematologic response rate was 39% (95% CI, 31%-48%).

Addressing Mealtime Restrictions

The prescribing information for Tasigna specifies that patients should avoid food for 2 hours prior to treatment and 1 hour after treatment due to variability in bioavailability, which increases when taken with food and could lead to a significantly prolonged QT interval. Danziten overcomes this limitation, offering a more convenient and patient-friendly treatment option.
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Reference News

[1]
FDA OKs Ninlotinib Tablets With No Mealtime Restrictions for CML - Oncology Nursing News
oncnursingnews.com · Nov 16, 2024

The FDA approved nilotinib (Danziten) without mealtime restrictions for adults with newly diagnosed or resistant/intoler...

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