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Novartis' Scemblix receives accelerated FDA approval for newly diagnosed Ph+ CML in adults

BASEL (dpa-AFX) – Novartis (NVS) announced that Scemblix (asciminib) received accelerated approval from the US Food and Drug Administration for adult patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukemia or received Ph+ CML-CP.

Accelerated approval is based on the major molecular response rate (MMR) at week 48 of the Phase III ASC4FIRST trial comparing Scemblix once daily with all other standard tyrosine kinase inhibitors (TKIs) selected by researchers (imatinib, nilotinib, dasatinib, etc.). .) Bosutinib was compared).

In the study, Scemblix demonstrated better MMR rates in both primary endpoints at week 48 compared to IS-SoC TKIs and imatinib alone. Further approval for the newly diagnosed indication may be contingent upon review and description of clinical benefit based on confirmatory evidence, the company said.

The company found that nearly 50% of patients with chronic myeloid leukemia do not achieve efficacy milestones (MMR) with the current standard of care and nearly 25% discontinue or switch therapy within one year of treatment.

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