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FDA grants priority review for Novartis’ leukaemia treatment

2024-07-30

临床3期临床结果细胞疗法优先审批上市批准

Novartis’ ASC4FIRST study enrolled 405 adult patients. Credit: Melnikov Dmitriy / Shutterstock.

Novartisood and Drug Administration (FDA) has granted priority review designation for Novartis’ Scemblix (asciminib) to treat newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

This stFood and Drug Administration (FDA)ments that could significantly improve the saNovartisefScemblixf asciminib for serious or life-threatening conditions.Philadelphia chromosome-positive chronic myeloid leukemia Ph+ CML-CP

The priority review for Scemblix is based on data from the Phase III ASC4FIRST clinical trial.

This trial assessed the Scemblix, tolerability and safety of Scemblix, administered once daily, compared to investigator-selected tyrosine kinase inhibitors (TKIs), which include imatinib, nilotinib, dasatinib and bosutinib and are considered the standard of care for newly diagnosed Ph+ CML-CP patients.

In the ASC4FIRST study, which enrolled 405 adult patients, SceScemblixmonstrated superior major molecular response (MMR) rates at week 48 versus the standard of care TKIs and imatiimatinibe.nilotinib dasatinib bosutinib Ph+ CML-CP

See Also:Cellipont Bioservices’ Cell Therapy Manufacturing Scemblix, Texas, USimatinib

Entos PhaCellipont Bioservicesical Manufacturing Facility, California, USA

Scemblix also showed superior efficacy along with a more favourable safety and tolerability profile versus imatinib and second-generation TKIs.

Entos Pharmaceuticalshibited fewer grade ≥3 adverse events and dose adjustments and half the rate of adverse events leading to treatment discontinuation.

The safety profile of Scemblix in newly diagnosed patients aligns with that observed in previous registration studies, with no new safety concerns reported.

Scemblix is already approved by the FDA, the European Medicines Agency and other regulatory authorities forimatinibadults with Ph+ CML-CP who have been treated previously with two or more TKIs.

Novartis US oncology therapeutic area head and senior vice-president Rodney Gillespie stated: “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 inScemblixhat 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.”

Scemblixany posted a significant 43%FDAcreaseEuropean Medicines Agencynuing operations, reaching $3.24bn in the second quarter Ph+ CML-CP24, up from $2.27bn in the same period of 2023.

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