FDA Approves Danziten Tablets, the First and Only Nilotinib with No Mealtime Restrictions
Azurity Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved Danziten. This is the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase, and in adult patients with chronic phase (CP), and acute phase (AP) resistant or intolerant to prior therapy that included imatinib.
- Tasigna® has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or
intolerant Ph+ CML-CP and CML-AP; however, Tasigna has variable bioavailability that considerably
increases when taken with food. - Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but
without the fasting requirements of Tasigna.
Source: Azurity Pharmaceuticals, Inc.
