The European Commission (EC) has approved Novartis’ Scemblix (asciminib) to treat chronic myeloid leukemia (CML) in adult patients.
Scemblix specifically targets the ABL myristoyl pocket, which is also called as a STAMP inhibitor in scientific literature.
It provides a new treatment approach for patients experiencing intolerance and/or resistance to existing tyrosine kinase inhibitors (TKI) therapies.
The drug is indicated for Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP), in adult patients who were previously treated with two or more TKIs.
The regulatory approval is applicable to 27 member states of the European Union along with Norway, Iceland, and Liechtenstein.
Novartis Europe Innovative Medicines president Haseeb Ahmad said: “Approval of Scemblix from the European Commission is a critical milestone to help bring this novel treatment to patients living with CML in Europe.
“Building on more than twenty years of innovation in CML, we are excited by the potential to once again transform the standard of care for more patients around the world.”
In June this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted positive opinion for the approval of Scemblix.
The EC approval is based on the data obtained from the Phase III ASCEMBL trial, in which participants treated with Scemblix experienced nearly double the major molecular response (MMR) rate compared to Bosulif (bosutinib).
Scemblix has also reduced the discontinuation rate due to adverse reactions by more than three times at week-24.
Upper respiratory tract infections, diarrhoea, increased pancreatic enzymes, musculoskeletal pain, fatigue, headache, arthralgia, abdominal pain, and nausea are the most common adverse reactions found in patients treated with Scemblix.