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2022-08-29| Trials & Approvals

Novartis’ Treatment for Rare Cancer Wins European Commission’s Approval

by Max Heirich
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On August 29, Novartis announced the European Commission (EC) approved their application for Scemblix® (asciminib). Scemblix treats adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). The EC based its approval on the Phase 3 ASCEMBL trial, in which Scemblix showed nearly double the major molecular response rate compared to a similar medication in treating this rare cancer. 

Related Article: Incyte’s Rare Cancer Drug Snags Second FDA Approval

The Efficacy of Scemblix in Treating Leukemia

The specific subset of leukemia treated by Scemblix is chronic myeloid leukemia (CML). This rare cancer occurs when the blood cells of a person’s chromosomes swap and a portion of chromosome 9 changes place with a part of chromosome 22. This new short chromosome is known as the Philadelphia chromosome. This new chromosome creates a new gene containing instructions for the blood cell. As a result, the cells produce too much of the protein tyrosine kinase, leading to cancer. 

Current treatments for CML include medications targeting and inhibiting the production of tyrosine kinase. One such drug is Pfizer’s BOSULIF® (bosutinib), prescribed to patients whose cancer no longer responds to other treatments. 

Similarly, Norvartis’ Scemblix inhibits the production of this protein. However, it also explicitly inhibits the ABL myristoyl pocket. The Phase 3 ASCEMBL trial compared the efficacy and safety of Scemblix to bosutinib. The results show that the major molecular response rate of Scemblix nearly doubled that of bosutinib (25.5% vs. 13.2%). In addition, patients discontinued the use of Scemblix due to adverse reactions far less than those taking bosutinib (5.8% vs. 21.1%).

This data built the foundation for the EC’s approval of Scemblix.

Scremblix Applicable to all 27 European Union Countries

In June, the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on Scemblix. That, in tandem with the results of the ASCEMBL trial, gained the EC’s approval of the drug. With the approval, Scemblix is now applicable to all 27 European Union countries, in addition to Iceland, Norway and Liechtenstein.

On the approval, Haseeb Ahmad, President of Europe Innovative Medicines at Novartis, said, “Approval of Scemblix from the European Commission is a critical milestone to help bring this novel treatment to patients living with CML in Europe. Building on more than twenty years of innovation in CML, we are excited by the potential to once again transform the standard of care for more patients around the world.”

The EC’s approval for this rare cancer treatment follows the United States Food and Drug Administration’s (FDA) in October 2021. In Europe alone, this rare cancer affects over 6,300 people a year. The approval of Scemblix marks another win for the fight against CML. 

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