The US Food and Drug Administration (FDA) has approved Cavhanza (nilotinib) orally disintegrating tablets for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
CML is a myeloproliferative neoplasm characterized by the expression of the BCR-ABL1 fusion gene. It presents with neutrophilic leukocytosis. It can appear at any age, but it mostly affects middle aged and older individuals. Patients usually present with fatigue, weight loss, anemia, night sweats, and splenomegaly. Allogeneic stem cell transplantation and tyrosine kinase inhibitors are traditional lines of therapy for this condition.
The approval is indicated for newly diagnosed adults with Ph+ CML in chronic phase and adults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.
Nilotinib is a kinase inhibitor, whose oral tablet formulation is designed to improve solubility and dissolution rate, enabling maintained bioavailability with concomitant use of acid-reducing agents such as proton pump inhibitors (PPIs) and/or H₂ antagonists (H₂RAs) without timing restrictions.
In clinical trials, nilotinib demonstrated no food effect and the ability to be taken without regard to meals, reducing food-related burden and supporting more flexible dosing. Additionally, this orally disintegrating tablet formulation of nilotinib may support patients who have difficulty swallowing while also offering flexibility to take the treatment with or without water.
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To learn more about CML and other rare cancers, visit https://checkrare.com/diseases/cancers/
