Priority Review Awarded by FDA for Novartis’ Leukaemia Treatment

For the treatment of recently diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic stage (Ph+ CML-CP), the FDA has awarded priority review status for Novartis’ Scemblix.

Scemblix’s Phase III ASC4FIRST clinical trial findings served as the foundation for the priority evaluation.

In this study, the once-daily administration of Scemblix was evaluated for its effectiveness, safety, and tolerability in comparison to investigator-selected tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, and bosutinib, which are thought to be the best option for treating newly identified Ph+ CML-CP patients.

Novartis US oncology therapeutic area head and senior vice-president Rodney Gillespie commented: “We welcome the FDA’s decision to grant priority review and breakthrough therapy designations to Scemblix for newly diagnosed CML patients, which underscores the substantial need for additional effective, safe and tolerable treatment options.

“The ASC4FIRST data indicate that Scemblix, if approved, has the potential to address a critical gap in CML by offering a highly effective treatment along with a favourable safety and tolerability profile.”