The U.S. Food & Drug Administration (FDA) has cleared Tasigna for use in children, even as a growing number of lawsuits accuse its manufacturer of downplaying the drug’s alleged link to arteriosclerosis and related complications.
Tasigna (nilotinib) belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which block a protein called Bcr-ABl to stop the growth of cancer cells. It was initially approved by the FDA in 2007 to treat adults suffering from Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML).
According to a statement released by the FDA on March 22nd, Tasigna’s approved indications have now been expanded to include pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior TKI therapy.
The expanded approval was granted under the FDA’s priority review designation. According to the agency, Tasigna’s known safety profile in pediatric patients is similar to the known safety profile in adults with Ph+ CML-CP.
Court records indicate that a Tasigna lawsuit was recently filed in the U.S. District Court, Eastern District of Washington, on behalf of a man who suffered a stroke after he was prescribed the leukemia drug. The plaintiff claims that his use of Tasigna resulted in rapidly progressing arteriosclerosis of the carotid arteries, which subsequently led to his stroke at the age of 66. (Case No. Case 3:18-cv-05149)
According to a March 2016 filing in the U.S. District Court, Eastern District of California, another patient developed peripheral artery disease shortly after he began taking Tasigna in 2012. He died of complications related to the condition 2014, even though his doctor changed his treatment after learning via a medical journal article that Tasigna had been linked to arteriosclerosis. (Case No. No. 16-393)
Both complaints note, among other things, that the Canadian label for Tasigna was updated with information about arteriosclerosis in 2013. The modifications were made after a review conducted by Health Canada discovered that 277 reports of the condition had been logged with the Novartis global safety database between January 1st, 2005 and January 31, 2013.