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FDA Updates Nilotinib CML Label With Discontinuation Provision

Jason M. Broderick @jasoncology
Published: Friday, Dec 22, 2017

Richard Pazdur, MD

Richard Pazdur, MD
The FDA has updated the label for nilotinib (Tasigna) 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. 

"It has long been our ambition at Novartis to make it possible for some people with CML to discontinue therapy," Bruno Strigini, CEO, Novartis Oncology, said in a press release. "We are proud that Tasigna is now the first and only TKI with TFR data in its labeling in the United States and several countries around the globe. This achievement would not have been possible without the partnership of patients around the world who participated in our groundbreaking TFR trials, helping Novartis to once again reimagine what is possible for people living with CML."
Novartis drug Tasigna is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label. Novartis. Available at: https://www.novartis.com/news/media-releases/novartis-drug-tasignar-approved-fda-first-and-only-cml-therapy-treatment-free-remission-data-its-label. Accessed December 22, 2017.

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