Novartis' Scemblix Receives Accelerated FDA Approval For Newly Diagnosed Ph+ CML In Adults

(RTTNews) - Novartis (NVS) announced that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase or Ph+ CML-CP.

The accelerated approval is based on major molecular response rate (MMR) 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 (TKIs) (imatinib, nilotinib, dasatinib, and bosutinib).

In the study, Scemblix demonstrated superior MMR rates in both primary endpoints at week 48 vs. IS SoC TKIs and imatinib alone. Continued approval for the newly diagnosed indication may be contingent upon verification and description of clinical benefit from confirmatory evidence, the company said.

The company noted that Nearly 50% of chronic myeloid leukemia patients do not meet efficacy milestones (MMR) with current standard of care and almost 25% discontinue or switch therapies within one year of treatments.

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