Novartis: Scemblix approved by FDA

(CercleFinance.com) - Novartis announces that Scemblix has been approved by the FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-PC).


The accelerated approval is based on the major molecular response (MMR) rate at week 48 of the ASC4FIRST phase III trial, which compared Scemblix once-daily to all other investigator-selected (IS) reference tyrosine kinase inhibitors (TKIs) (imatinib, nilotinib, dasatinib and bosutinib).

In the study, Scemblix demonstrated superior MMR rates in both primary endpoints at week 48 compared to the reference TKIs IS and imatinib alone 1 - 3.

Newly diagnosed patients will now have access to a treatment that has demonstrated superior efficacy to all standard therapies and a favorable safety and tolerability profile, it says.


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