Novartis Secures First-Line Approval for Scemblix in Newly Diagnosed Chronic Myeloid Leukemia Patients

Approval:
The US FDA granted accelerated approval for Scemblix (asciminib) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

Efficacy:
Scemblix demonstrated superior major molecular response (MMR) rates compared to standard of care tyrosine kinase inhibitors (TKIs) in the ASC4FIRST Phase III trial.

Safety and Tolerability:
Scemblix showed a favorable safety and tolerability profile with fewer grade ≥3 adverse events, dose reductions, and half the rate of adverse reactions leading to treatment discontinuation compared to standard of care TKIs.

Mechanism of Action:
Scemblix is the first CML treatment that specifically targets the ABL myristoyl pocket (STAMP inhibitor), offering a novel approach for patients who experience intolerance and/or resistance to currently available TKI therapies.

Market Impact:
Novartis projects peak sales of $3 billion for Scemblix with this first-line expansion.

Regulatory Status:
Scemblix is now approved for both newly diagnosed and previously treated CML patients, expanding its potential reach to more patients.