Novartis Scemblix receives positive CHMP opinion for the treatment of adults with newly diagnosed CML

• If approved, Scemblix will be indicated for adults with chronic myeloid leukemia (CML), both newly diagnosed and previously treated, expanding access to four times as many patients in Europe
  
  
• Scemblix is the only CML treatment with a superior efficacy and favorable safety and tolerability profile versus available first-line treatments^1,2
  
  
• Despite available first-line treatments, 50% of patients newly diagnosed with CML miss treatment goals within one year, many of whom experience adherence challenges due to treatment tolerability^3,4

Basel, October 17, 2025 – Novartis announced today 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^1,2. 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^1,2. Patients treated with Scemblix also required fewer dose reductions and experienced half the rate of adverse events leading to discontinuation^1,2.

"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."