Novartis says Scemblix FDA approved in newly diagnosed CML

Novartis (NVS) announced that Scemblix was granted accelerated approval by the U.S. Food and Drug Administration for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. “The accelerated approval is based on major molecular response rate at week 48 from the ASC4FIRST Phase III trial that compared once daily Scemblix to all other investigator-selected standard of care tyrosine kinase inhibitors. In the study, Scemblix demonstrated superior MMR rates in both primary endpoints at week 48 vs. IS SoC TKIs and imatinib alone1-3. Continued approval for the newly diagnosed indication may be contingent upon verification and description of clinical benefit from confirmatory evidence. The expanded indication in Ph+ CML-CP increases the population eligible for Scemblix by approximately four times, including newly diagnosed and previously treated adults. Newly diagnosed patients will now have access to a treatment that has shown superior efficacy vs. all standard of care therapies and a favorable safety and tolerability profile,” the company stated.