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# FDA OKs Expanded Indication for Novartis’ Tasigna
- URL: https://www.fdaweb.com/fda-oks-expanded-indication-for-novartis-tasigna/
- Published: 2018-03-22T12:00:00.000Z
- Updated: 2026-09-14T23:54:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141046

FDA has approved an expanded indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). Previously, the product was approved for treating adult patients with newly diagnosed Ph+ CML-CP. CML is a type of blood cancer where the body produces malignant white blood cells, according to the company. Almost all CML patients have an abnormality known as the “Philadelphia chromosome,” which produces a protein called BCR-ABL, which aids the proliferation of malignant white blood cells in affected patients, it says.