Novartis Scemblix receives positive CHMP opinion for newly diagnosed CML in adults
Basel: Novartis has 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 leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.
“For people living with CML, long-term therapy can be physically and emotionally demanding, and many face challenges in reaching treatment milestones without compromising quality of life,” said David FitzGerald, Member of the CML Advocates Network. “The availability of more treatment options earlier in the care pathway is a welcome development that brings forward additional possibilities for patients and their healthcare teams to choose approaches that best support both clinical goals and patient well-being.”
The positive CHMP opinion is based on data from the Phase III ASC4FIRST trial, which compared Scemblix with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in patients with newly diagnosed Ph+ CML-CP. In the trial, Scemblix demonstrated superior major molecular response (MMR) rates when compared against all TKIs (imatinib, nilotinib, dasatinib and bosutinib) and also when compared against imatinib alone. Patients treated with Scemblix also required fewer dose reductions and experienced half the rate of adverse events leading to discontinuation.
"To give patients newly diagnosed with CML the best chance to reach key efficacy milestones while maintaining quality of life, it is critical to intervene early with a more selective treatment that combines superior efficacy with tolerability," said Professor Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology at Jena University Hospital, Germany. "If approved, Scemblix could provide patients with a well-tolerated option that may deliver faster, deeper and longer-lasting molecular response with fewer treatment discontinuations due to adverse events, compared with available first-line treatments — potentially paving the way for more patients to reach treatment-free remission."
Scemblix is approved in earlier lines in more than 20 countries, including the US, Japan and China. Scemblix is recommended for the treatment of patients with newly diagnosed Ph+ CML-CP by the 2025 European LeukemiaNet recommendations for the management of CML and by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines). Since 2021, Scemblix has been a standard of care (SoC) in more than 80 countries for patients previously treated with two or more TKIs.
“People newly diagnosed with CML need treatments that deliver both better efficacy and excellent tolerability to achieve early, deep molecular response, which is critical to achieve long-term outcomes like treatment-free remission,” said Patrick Horber, M.D., President, International, Novartis. “Scemblix is the only treatment that has demonstrated superior efficacy and tolerability compared to current first-line treatments. The positive CHMP opinion marks a major milestone in our 25-year journey to improve CML care and could help establish a new standard of care in Europe."
Following the CHMP’s recommendation to approve Scemblix for the treatment of adults with Ph+ CML-CP in all lines of treatment, the European Commission (EC) will make a final decision within two months.
Next Story