Scemblix Is First-in-Class STAMP Inhibitor for CML

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). The drug’s novel mechanism of action may offer an improvement over other therapies within the class, industry experts say.

On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.