publication date: Mar. 23, 2018
Drugs and Targets
Novartis’s Tasigna approved for children with rare form of leukemia
Novartis announced the FDA has expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
In the U.S., Tasigna is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP. Tasigna is also indicated for the treatment of pediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib.
This approval is the latest in a series of regulatory milestones that broadens the understanding and clinical use of Tasigna.
CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the “Philadelphia chromosome,” which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients. Worldwide, CML accounts for approximately 3% of newly diagnosed childhood leukemia.
The new indications, granted under the FDA’s Priority Review designation, are based on two studies evaluating the efficacy and safety of nilotinib in pediatric patients (two years to less than 18 years of age) with Ph+ CML-CP. A total of 69 Ph+ CML-CP pediatric patients, either newly diagnosed (first-line) or who were resistant or intolerant to prior TKI therapy (second-line), received nilotinib.
In newly diagnosed pediatric patients, the major molecular response (MMR; BCR ABL/ABL … Continue reading Novartis’s Tasigna approved for children with rare form of leukemia
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