MedPath

Nilotinib

Generic Name
Nilotinib
Brand Names
Tasigna, Nilotinib Accord
Drug Type
Small Molecule
Chemical Formula
C28H22F3N7O
CAS Number
641571-10-0
Unique Ingredient Identifier
F41401512X
Background

Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.

Indication

For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).

Associated Conditions
Accelerated Phase Chronic Myelogenous Leukemia (CML), Chronic Phase Chronic Myeloid Leukemia, Newly diagnosed, chronic phase Chronic myeloid leukemia, Refractory Gastrointestinal stromal tumor
Clinical Trials
Related News

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Novartis' 'Wild Card' Drug Scemblix Receives FDA Approval for Leukaemia Treatment

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Non-ABL1 Mutations Impact Outcomes in Chronic Myeloid Leukemia

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Olverembatinib Shows Promise as Second-Line Therapy for Chronic Phase CML

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FDA Approves Danziten, a Novel Nilotinib Formulation Without Mealtime Restrictions, for CML

• The FDA has approved Danziten (nilotinib), a new formulation for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) without mealtime restrictions. • Danziten offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose and eliminating the need for fasting, potentially improving patient adherence. • The approval covers adult patients with newly diagnosed Ph+ CML in chronic phase and those resistant or intolerant to prior therapy, including imatinib. • Azurity Pharmaceuticals will launch Danziten in the coming weeks with patient support programs to enhance access and adherence.

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.

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

• The FDA has approved nilotinib (Danziten) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). • This approval includes patients in chronic phase (CP) and accelerated phase (AP) who are resistant or intolerant to prior imatinib therapy. • Danziten is the first nilotinib formulation that eliminates mealtime restrictions, offering improved convenience for patients. • The new formulation has improved bioavailability, allowing for consistent nilotinib exposure regardless of fasting state or meal type.

Novartis and Apellis Advance C3G Therapies Towards FDA Submission

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FDA Approves Danziten (Nilotinib) for Chronic Myeloid Leukemia Without Fasting Requirement

• The FDA has approved Danziten, a new formulation of nilotinib, for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML). • Danziten does not require fasting, potentially improving patient adherence compared to Tasigna, another nilotinib formulation. • This approval covers newly diagnosed CML and cases resistant or intolerant to prior Gleevec (imatinib) therapy. • Danziten offers equivalent efficacy to Tasigna with improved bioavailability and consistent pharmacokinetics regardless of meal timing.

FDA Approves New Nilotinib Formulation (Danziten) for Chronic Myeloid Leukemia Without Mealtime Restrictions

• The FDA has approved Danziten (nilotinib), a new formulation of nilotinib, for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). • Danziten is the first and only nilotinib formulation that does not require mealtime restrictions, offering improved convenience for patients. • Clinical trials demonstrated that Danziten has equivalent efficacy to Tasigna but with enhanced bioavailability, allowing for a lower dose and eliminating the need for fasting. • The approval of Danziten provides a new treatment option that may improve patient adherence and lessen the burden of CML treatment.

FDA Approves Azurity's Danziten (Nilotinib) for CML Without Mealtime Restrictions

• The FDA has approved Azurity Pharmaceuticals' Danziten (nilotinib) as the first nilotinib formulation for chronic myeloid leukemia (CML) without mealtime restrictions. • Danziten is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase and those resistant or intolerant to prior imatinib therapies. • The reengineered formulation of Danziten offers equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage and potentially improving patient adherence. • Danziten is expected to be available soon through Biologics by McKesson and Limited Specialty Distribution, offering a more convenient treatment option for CML patients.

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

• The FDA has approved nilotinib tablets (Danziten) without mealtime restrictions for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML). • Danziten is also approved for CML patients resistant or intolerant to prior imatinib therapy, offering an alternative treatment option. • This new formulation of nilotinib boasts improved bioavailability, allowing for a lower dose and eliminating the need for fasting, unlike Tasigna. • Clinical trials, including ENESTnd, demonstrated nilotinib's efficacy in achieving major molecular responses in CML patients compared to imatinib.

FDA Approves Danziten, a Nilotinib Formulation for CML Without Mealtime Restrictions

• The FDA has approved Danziten (nilotinib) for chronic myeloid leukemia (CML), offering a new treatment option without the strict fasting requirements of Tasigna. • Danziten provides comparable efficacy to Tasigna with consistent pharmacokinetics, even without fasting, potentially improving patient adherence to treatment regimens. • This tyrosine kinase inhibitor (TKI) is approved for newly diagnosed Philadelphia chromosome-positive CML and those resistant or intolerant to prior therapies, including imatinib. • Azurity Pharmaceuticals will offer Danziten through a specialty network and patient support program, enhancing access and adherence for CML patients.

FDA Approves Nilotinib Tablets (Danziten) Without Mealtime Restrictions for CML

• The FDA has approved nilotinib tablets (Danziten) for Philadelphia chromosome-positive chronic myeloid leukemia (CML) patients, offering a new treatment option. • Danziten eliminates the need for fasting, unlike the original nilotinib formulation (Tasigna), which required strict mealtime restrictions to avoid cardiotoxicity. • The approval includes newly diagnosed CML patients and those with resistance or intolerance to prior therapy, including imatinib. • This new formulation provides equivalent efficacy to Tasigna but without the boxed warning requirement for fasted-state administration, improving patient convenience.

FDA Approves Danziten (Nilotinib) as First Meal- unrestricted Option for CML Patients

• The FDA has approved Danziten (nilotinib) for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and those resistant or intolerant to prior therapies. • Danziten is the first nilotinib formulation that does not require fasting, offering equivalent efficacy to Tasigna but with improved bioavailability and a lower dose. • This new formulation may improve patient adherence to treatment, as it removes the burden of strict mealtime restrictions associated with other nilotinib products. • Danziten will be available through Biologics by McKesson and Limited Specialty Distribution, supported by the DanzitenCONNECT patient support program.

FDA Approves Danziten (nilotinib) for CML Patients Without Mealtime Restrictions

• The FDA has approved Danziten, a new formulation of nilotinib, for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). • Danziten is the first and only nilotinib formulation that does not require mealtime restrictions, offering improved convenience for patients. • This approval provides an alternative to Tasigna with equivalent efficacy but without the strict fasting requirements, potentially improving patient adherence. • Danziten is indicated for newly diagnosed Ph+ CML in chronic phase and for chronic or acute phase CML resistant or intolerant to prior therapies.

FDA Approves Danziten (nilotinib) as First Nilotinib Formulation Without Mealtime Restrictions for CML

• The FDA has approved Danziten (nilotinib) for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), both newly diagnosed and resistant/intolerant cases. • Danziten is the first nilotinib formulation that does not require fasting, offering equivalent efficacy to Tasigna with improved bioavailability and a lower dose. • This new formulation may improve patient adherence to treatment, as it removes the burden of strict mealtime restrictions previously associated with nilotinib therapy. • Danziten will be available through Biologics by McKesson and Limited Specialty Distribution, supported by the DanzitenCONNECT patient support program.

Nilotinib Shows Promise in Dementia with Lewy Bodies

• A phase II trial of nilotinib in patients with dementia with Lewy bodies (DLB) showed improved cognition scores compared to placebo. • The study also found that nilotinib significantly increased brain dopamine levels and reduced the ratio of p-tau181 to amyloid-beta 42 in cerebrospinal fluid. • Nilotinib was safe and well-tolerated, with fewer adverse events, including falls, compared to the placebo group. • Researchers suggest further investigation of tyrosine kinase inhibitors for neurodegenerative diseases like Parkinson's, Alzheimer's, and DLB.
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