SWITZERLAND- The European Commission (EC) has authorized Scemblix® (asciminib) for the treatment of adult patients with chronic myeloid leukemia.
This is in patients with the Philadelphia chromosome in the chronic phase (Ph+ CML-CP), who have previously received treatment with two or more tyrosine kinase inhibitors (TKIs).
Scemblix is the first CML medication in Europe that directly targets the ABL myristoyl pocket (also referred to as a STAMP inhibitor) for patients who exhibit intolerance and/or resistance to presently existing TKI medicines
It is effective in all 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein.
The approval comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June issued a favorable opinion and designated Scemblix as an orphan drug.
The approval is based on the pivotal Phase III ASCEMBL trial’s findings, which demonstrated a nearly doubling of the MMR rate for patients treated with Scemblix compared to Bosulif®* (bosutinib).
“Approval of Scemblix from the European Commission is a critical milestone to help bring this novel treatment to patients living with CML in Europe,” said Haseeb Ahmad, President, Europe Innovative Medicines, Novartis.
He added that building on more than twenty years of innovation in CML, they are excited by the potential to once again transform the standard of care for more patients around the world.
The majority of persons with chronic leukemias can live for many years before they experience any symptoms. But compared to acute leukemias, chronic leukemias are typically more difficult to treat.
Chronic myeloid leukemia is a type of cancer that starts in certain blood-forming cells of the bone marrow. Cells partially mature but do not fully develop in chronic leukemia.
Despite appearing to be somewhat normal, these cells are not. In general, they do not combat infection as effectively as regular white blood cells do.
In the bone marrow, the leukemia cells proliferate, accumulate, and drown out healthy cells while living longer than healthy cells.
The majority of persons with chronic leukemias can live for many years before they experience any symptoms. But compared to acute leukemias, chronic leukemias are typically more difficult to treat.
Adult leukemia is claimed to have annual incidence rates of 0.6 to 2.0 cases per 100,000 person-years or 10-15% of all newly diagnosed cases.
In Europe, it is anticipated that more than 6,300 persons will receive a CML diagnosis each year.
While many patients will benefit from the TKI therapies that are now accessible, a sizeable number may develop intolerance or resistance to these medications.
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