Novartis' Scemblix Snags European Approval For Chronic Myeloid Leukemia

  • The European Commission (EC) has approved Novartis AG's NVS Scemblix (asciminib) for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). 
  • Scemblix is the first CML treatment in Europe that works by specifically targeting the ABL myristoyl pocket (also known as a STAMP inhibitor in scientific literature).
  • Patients with CML generally receive oral tyrosine kinase inhibitor therapies, and those experiencing side effects or resistance have little hope of controlling their disease, the company said in a statement.
  • The approval is based on results from the Phase 3 ASCEMBL trial, which showed a near doubling in MMR rate for patients treated with Scemblix vs. Pfizer Inc's PFE Bosulif (bosutinib) (25.5% vs. 13.2%).
  • Data also showed more than three times a lower discontinuation rate due to adverse reactions (5.8% vs. 21.1%).
  • Price Action: NVS shares are up 0.44% at $83.04 during the premarket session on the last check Monday.
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