FDA Drug Information Update or Tasigna

PUBLISHED: Dec 26, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office, Pharmacy

The US Food and Drug Administration (FDA) has updated the product label for the cancer drug, Tasigna (nilotonib), to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). The updated dosing recommendations are for patients with early (chronic) phase CML who have been taking Tasigna for three 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. These patients may be eligible to stop taking Tasigna.

The information about discontinuing Tasigna was based on two single-arm trials of patients with Ph+ chronic phase CML. The trials measured how long patients were able to stop taking Tasigna without the leukemia returning (treatment-free remission, or TFR). In both trials, patients had to meet rigorous criteria showing how their cancer had responded to treatment before stopping Tasigna. An important part of both trials was regular and frequent monitoring of specific genetic (RNA) information that specifies the BCR-ABL protein level in the blood with a diagnostic test that has received FDA marketing authorization. Monitoring with a test able to detect reductions of specific RNA information with high accuracy and precision is critical to the safe discontinuation of Tasigna, as this monitoring provides the first signs of relapse.

Follow the link below for additional information including common side effects when taking or discontinuing Tasigna and for additional label warnings.

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