EMA committee recommends marketing approval for Novartis Scemblix to treat adult patients with chronic myeloid leukaemia

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). If approved, Scemblix will be the first CML treatment in Europe that works by specifically targeting the ABL myristoyl pocket (also known as a STAMP inhibitor in scientific literature), representing an important therapeutic advancement for patients who experience intolerance and/or resistance to currently available TKI therapies. It is estimated that, every year, more than 6,300 people will be diagnosed with CML in Europe. While many patients will benefit from available TKI therapies, a significant proportion may experience intolerance or resistance to these treatments. In an analysis of patients with CML treated with two prior TKIs, approximately 55% reported intolerance to previous treatment; and a pooled analysis of patients in the second-line setting revealed that up to 70% are unable to achieve major molecular response (MMR) within two years of follow-up. "Although CML treatments have advanced over the last 20 years, many patients continue to experience side effects and resistance to treatment, affecting their quality of life and putting them at risk of disease progression or even death," says Dr. Andreas Hochhaus, Head of the Department of Haematology and Medical Oncology at Jena University Hospital in Germany. "If approved, the novel mechanism of action of Scemblix brings us another option to combat these challenges faced by patients

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