Asciminib

Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile. Scemblix now approved for newly diagnosed and previously treated CML, allowing four times the patients access to potential new standard of care.
Scemblix is an orally available tyrosine kinase inhibitor that works by blocking the BCR-ABL1 fusion protein, a known hallmark of certain leukemias. The drug was first approved for CML three years ago, winning two indications. The first is for the treatment of Philadelphia chromosome-positive, chronic phase CML, for which the drug was given accelerated approval. The second is a full approval for the same patient population, with the additional specification that they carry the T315I mutation.