Novartis AG is leveraging its heritage in chronic myeloid leukemia as it launches Scemblix (asciminib), a new option for patients who have failed on or developed resistance to tyrosine kinase inhibitors (TKIs), including its own standard of care therapy Gleevec (imatinib), now available generically, and follow-on Tasigna (nilotinib).
The US Food and Drug Administration approved Scemblix on 29 October for two CML indications. The first is an accelerated approval for adults with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more TKIs. The second is a full approval for patients with Ph+ CML-CP harboring the T315I mutation, which can develop in some patients following treatment
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