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FDA Grants New Nilotinib Formulation Approval to Treat Adults With Chronic Myeloid Leukemia
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The tablets become the first and only nilotinib with no mealtime restrictions indicated for this population.
The FDA granted regulatory approval to nilotinib tablets (Danziten; Azurity Pharmaceuticals), becoming the first and only nilotinib with no mealtime restrictions indicated for adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, according to a news release from Azurity Pharmaceuticals.1
Chronic myeloid leukemia can pose a significant burden to patients. | Image Credit: © Saiful52 | stock.adobe.com
Nilotinib is also indicated for adult patients with chronic phase and acute phase resistance or intolerance to prior therapy that included imatinib (Gleevac; Novartis).1
Tasigna, another version of nilotinib, has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP. However, it features variable bioavailability that considerably increases when taken with food. Critically, it could significantly prolong QT interval on surface electrocardiogram when taken with food; therefore, strict fasting is required when taking Tasigna.1
A poster presented by Radich et al at the Society of Hematology Oncology 2024 Annual World conference September 2024 in Houston indicated the efficacy of Danziten as a re-engineered formulation of nilotinib without mealtime restrictions.2
Most importantly, this new formulation offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose and no required food-related restrictions when taking the drug. In clinical trials, re-formulated nilotinib demonstrated consistent pharmacokinetics and no clinically significant differences in exposure regardless of fasting state or meal type, with the same efficacy nilotinib has previously indicated.2,3
“Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in the news release. “Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions.”1
Tyrosine kinase inhibitors (TKIs) have increasingly demonstrated success in clinical trials of patients with CML, who can face many obstacles when managing their treatment and must avoid adverse outcomes. Due to the advancements in TKIs for CML, the overall survival rate of those with CML has become close to the normal population. New indications, such as Danziten, can help patients lessen the burden of CML treatment.4
“We need to deliver the lowest dose that can maintain efficacy without long term measurable adverse events,” Elias Jabbour, MD, fellow from the Anderson Cancer Center in Houston, said during a presentation at the SOHO meeting in September. Conferences attendees noted that mutations in CML—such as Ph+ CML—can significantly affect patient response or resistance to treatment.4
New treatments like Danziten can help patients with these mutations, especially if they present with chronic disease. Additionally, because of the removal of fasting requirements, patient adherence could be improved with newly formulated nilotinib.1,4
REFERENCES
1. Azurity Pharmaceuticals. Azurity Pharmaceuticals, Inc announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions. News Release. Released November 14, 2024. Accessed November 15, 2024. https://azurity.com/azurity-pharmaceuticals-inc-announces-fda-approval-of-danziten-nilotinib-tablets-the-first-and-only-nilotinib-with-no-mealtime-restrictions/
2. Radich J, Mauro M, Jain P, et al. Population pharmacokinetic (PopPK) modeling for a novel nilotinib formulation. Presented at: SOHO 2024 Annual World; September 4-7, 2024; Houston, TX.
3. Hochhlaus A, Masszi T, Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31(7):1525-1531. doi:10.1038/leu.2017.63
4. Gerlach A. New perspectives in CML management: Personalized approaches and adaptive strategies. Pharmacy Times. Published September 5, 2024. Accessed November 15, 2024. https://www.pharmacytimes.com/view/new-perspectives-in-cml-management-personalized-approaches-and-adaptive-strategies
