Novartis sNDA for Scemblix Expanded Use

FDA has accepted for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drug’s expanded use in treating newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Currently, Scemblix is approved for adult patients with Ph+ CML-CP who have been treated previously with two or more tyrosine kinase inhibitors.

The submission is based on data from the Phase 3 ASC4FIRST study comparing Scemblix against investigator-selected (IS) tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib, and bosutinib), which are the standard-of-care (SoC). “Scemblix demonstrated superior major molecular response (MMR) rates in both primary endpoints at week 48 vs. IS SoC TKIs (68% vs. 49.0%) and imatinib alone (69% vs. 40%),” Novartis says. “In newly diagnosed patients, the safety profile was consistent with previous registration studies, with no new safety concerns observed.”