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On July 29, Novartis announced that the FDA granted priority review to the marketing application for Scemblix (asciminib) for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).This priority review is based on the positive results of the pivotal Phase III ASC4FIRST study. ASC4FIRST is the first and currently the only Phase III trial to conduct a randomized head-to-head comparison with approved standard treatments (i.e., first- and second-generation TKIs).This study is a multicenter, randomized, open-label, head-to-head clinical trial (n=405) that evaluated the efficacy and safety of Scemblix (80mg, once daily) compared to investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib, or bosutinib) in newly diagnosed Ph+ CML-CP1 adult patients. The two primary endpoints of the study were the proportion of patients achieving major molecular response (MMR) at week 48, comparing the efficacy of Scemblix versus investigator-selected TKIs overall and Scemblix versus imatinib (in the subgroup of patients where imatinib was the TKI selected by investigators prior to randomization).The results showed that the study met both primary endpoints.The results are clinically and statistically significant. Specifically, in the full analysis set (FAS), the MMR rate in the Scemblix group was superior to that in the standard-of-care TKI group (67.7% vs. 49.0%, p<0.001); compared with the imatinib group, the MMR rate in the Scemblix group was also significantly higher (69.3% vs. 40.2%, p<0.001).Compared with standard-of-care TKIs, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events (AEs) and treatment discontinuations; no new safety signals were observed.Scemblix is the first STAMP inhibitor to act by specifically targeting the ABL myristoyl pocket. It is designed with high specificity to minimize off-target effects, and its safety and tolerability are improved compared to the current standard of care. In October 2021, Scemblix was approved for marketing in the United States for the treatment of...Adult patients with Ph+ CML-CP who have received two or more TKI treatments or have the T315I mutation.Disclaimer:
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