Novartis announced that the US FDA had approved Scemblix (asciminib) for treating patients with chronic myeloid leukemia.
Scemblix received accelerated approval for chronic Philadelphia chromosome-positive CML (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs) and complete approval for adult patients with Ph+ CML-CP with the T315I mutation.
Scemblix acts by inhibiting the ABL myristoyl pocket. The product is also called a STAMP inhibitor. Among the patients who were treated with two TKIs, 55% of patients are intolerant to earlier treatments.
The approval is based on the Phase III ASCEMBL trial; in addition to this, Novartis has submitted the phase I trial. The study included patients with Ph+ CML-CP with the T315I mutation.
In the ASCEMBL study, at week 24, Scemblix doubled molecular response rate versus Bosulif. Further, the proportion of patients who discontinued the treatment because of adverse events were three folds lower in the Scemblix arm.
The company has announced that it has initiated the process of regulatory filings in other countries.