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6-K: Novartis Scemblix® FDA Approved in Newly Diagnosed CML

SEC ·  Oct 29, 2024 20:11

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.
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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