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Novartis Pharma AG announced today that the US Food and Drug Administration Administration ( the FDA ) approved Scemblix ® (asciminib) for the treatment of chronic myeloid leukemia (CML)
.
Based on the primary molecular response (MMR) rate at 24 weeks, the FDA has accelerated the approval of Scemblix for the Philadelphia chromosome-positive CML chronic phase (Ph+ CML-CP) that has been treated with two or more tyrosine kinase inhibitors (TKI).
Manage FDA
For many patients, current CML treatments may be limited by intolerance or drug resistance, and continuous use of available TKIs is associated with increased failure rates
.
In an analysis of CML patients who had received two previous TKI treatments, approximately 55% of patients reported intolerance to the previous treatment
Scemblix provides a much-needed and long-awaited new option for chronic myelogenous leukemia (CML) patients who have experienced intolerance or under-reaction after at least two prior tyrosine kinase inhibitor (TKI) treatments
.
In the pivotal Phase III ASCEMBL trial, Scemblix showed a significant and clinically significant advantage in the rate of major molecular response (MMR) compared to Bosulif (25% vs.
13%) at 24 weeks , And the discontinuation rate due to side effects is low (7% vs.
25%)
.
13%) at 24 weeks , And the discontinuation rate due to side effects is low (7% vs.
25%)
.
In the pivotal Phase III ASCEMBL trial, Scemblix showed a significant and clinically significant advantage in the rate of major molecular response (MMR) compared to Bosulif (25% vs.
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