FDA updates cancer drug label to reflect that certain patients may be eligible to stop treatment after sustained response – APhA submits compounding comments to FDA. – (866) 348-2889
FDA on December 22 updated the product label for the cancer drug nilotonib (Tasigna—Novartis Pharmaceuticals) to include information for providers about how to discontinue the drug in certain patients. The drug is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking nilotonib for 3 years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking the drug. “Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.