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.