Nilotinib Tablets Approved by FDA for Ph+ CML in Chronic Phase

The FDA has approved nilotinib tablets (Danziten), without mealtime restrictions, for patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (CML), according to a press release from developers Azurity Pharmaceuticals, Inc.

The indication also includes patients who are in chronic phase or acute phase with resistance or intolerance to prior therapy that included imatinib (Gleevec).

Additionally, the original formulation of nilotinib (Tasigna) has variable bioavailability, which increases when taken with food. The press release states that a significant QT prolongation interval on surface electrocardiogram may present inappropriately when treatment with the original formulation is taken with food. Strict fasting is thus enforced to avoid cardiotoxicity with the previous formulation.

“[Nilotinib tablets] offer a new nilotinib treatment option with the equivalent efficacy to [nilotinib], but without the fasting requirements of [nilotinib],” Richard Blackburn, chief executive officer of Azurity Pharmaceuticals, Inc, said in the press release. “Unlike [nilotinib], the boxed warning on the [nilotinib tablets] label has no requirement for patients to take their medication in a fasted state, liberating patients with CML from mealtime restrictions.”

Reference

Azurity Pharmaceuticals, Inc. announces FDA approval of DANZITEN (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions. News release. Azurity Pharmaceuticals, Inc. November 14, 2024. Accessed November 14, 2024. https://tinyurl.com/yc7ttwkf