Posted by Michael Wonder on 22 Dec 2017
FDA updates the label of Tasigna to reflect that certain patients with a type of leukaemia may be eligible to stop treatment after sustained response
22 December 2017 - Discontinuation in treatment marks a first in chronic myeloid leukaemia.
The U.S. FDA today updated the product label for the cancer drug Tasigna (nilotinib) 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 chronic myeloid leukaemia.
With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukaemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorisation, may be eligible to stop taking Tasigna.
The update to the Tasigna labelling information was granted priority review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Tasigna also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
