Summary by Moomoo AI
Novartis announced FDA accelerated approval of Scemblix (asciminib) for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The approval is based on the Phase III ASC4FIRST trial showing superior efficacy versus all standard of care therapies.The trial demonstrated that 68% of Scemblix-treated patients achieved major molecular response (MMR) versus 49% for standard therapies at week 48. Scemblix showed a favorable safety profile with fewer treatment-related grade ≥3 adverse reactions (25.5% vs. 33%), lower dose reductions (6% vs. 14%), and half the discontinuation rate (4.5% vs. 11%) compared to standard treatments.The expanded indication increases the eligible patient population by approximately four times. The approval addresses an important unmet need, as nearly 50% of CML patients do not meet efficacy milestones and almost 25% discontinue or switch treatments within one year. The ASC4FIRST trial continues with next analysis scheduled at week 96.
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