Novartis has announced that the FDA has granted Priority Review status to Scemblix® (asciminib) for treating newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase. This designation is given to drugs that address serious conditions and offer significant improvements over existing treatments.

Scemblix also received Breakthrough Therapy designation, which underscores its potential to provide substantial benefits compared to current therapies. The drug is currently under the FDA’s Real-Time Oncology Review (RTOR) program. Previously, Scemblix was granted Priority Review and Breakthrough Therapy designations for patients with Ph+ CML-CP who had already been treated with at least two other tyrosine kinase inhibitors (TKIs).

Rodney Gillespie, Senior Vice President and Therapeutic Area Head for US Oncology at Novartis, praised the FDA’s decision, noting that Scemblix could fill a significant gap in CML treatment by offering a highly effective therapy with a favorable safety profile.

The Priority Review status is based on data from the ASC4FIRST Phase III trial, which compared Scemblix to various TKIs (imatinib, nilotinib, dasatinib, and bosutinib), the current standard treatments. Results showed that Scemblix achieved superior major molecular response (MMR) rates at 48 weeks compared to both the standard of care TKIs (68% vs. 49.0%) and imatinib alone (69% vs. 40%). Scemblix also had fewer severe adverse events, dose adjustments, and treatment discontinuations compared to imatinib and second-generation TKIs.

The ASC4FIRST data were highlighted at major oncology conferences and published in The New England Journal of Medicine.

Scemblix is already approved in various countries for Ph+ CML-CP patients who have previously used at least two TKIs. It is also approved for patients with the T315I mutation in some regions.

Scemblix offers a new approach by specifically targeting the ABL myristoyl pocket, unlike other CML treatments that focus on the ATP-binding site. Novartis continues to push the boundaries of CML treatment through ongoing research and their long-standing collaboration with the Max Foundation, which has helped provide access to critical therapies for over 100,000 patients in lower-income countries.

 

Source: novartis.com

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