FDA Updates Nilotinib CML Label With Discontinuation Provision

December 22, 2017 – The FDA has updated the label for nilotinib with a provision stipulating that patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor for at least 3 years and have achieved specific predetermined criteria may be eligible to stop treatment. Specifically, the label states that to discontinue treatment, patients must achieve a sustained … (leggi tutto)