Swiss drug major Novartis (NVS) announced Monday that the US Food and Drug Administration approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia or CML in two distinct indications.
The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors or TKIs, based on major molecular response (MMR) rate at 24 weeks.
The FDA also granted full approval for adult patients with Ph+ CML-CP with the T315I mutation.
In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence.
The company noted that Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies.
Scemblix, also known as a STAMP inhibitor in scientific literature, is being studied across multiple treatment lines for CML-CP, including the ASC4FIRST Phase III study evaluating Scemblix as a first-line treatment.
The FDA approval of Scemblix is based on results from the Phase III ASCEMBL trial and a Phase I (NCT02081378) study that included patients with Ph+ CML-CP with the T315I mutation.
Scemblix is currently available for physicians to prescribe to appropriate patients in the US. Novartis said it has initiated regulatory filings for Scemblix in multiple countries and regions across the globe.
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