Asciminib Receives Accelerated Approval for Chronic Phase Ph+ CML

By Melissa Badamo - Last Updated: October 30, 2024

Asciminib (Scemblix®) was granted accelerated approval by the US Food and Drug administration (FDA) for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), according to a press release from Novartis, the manufacturer of the drug.

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The approval is based on results of the phase III ASC4FIRST trial, which evaluated the efficacy of asciminib compared with imatinib alone and other investigator-selected tyrosine kinase inhibitors (TKIs) such as nilotinib, dasatinib, and bosutinib. Asciminib showed superior molecular response rates at week 48 compared to imatinib alone (69% vs 40%, respectively; 95% CI, P < 0.001) and compared to investigator-selected TKIs (68% vs 49%, respectively; 95% CI, P < 0.001).

The safety profile of asciminib was consistent with previous studies. The most common adverse events were musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea.

“While there are a range of effective TKIs currently available for newly diagnosed patients, clinicians frequently have had to weigh sacrificing either efficacy or tolerability,” Jorge Cortes, MD, Director of the Georgia Cancer Center and study investigator, said in the press release. “In the first-of-its-kind ASC4FIRST trial, [asciminib] achieved impressive results across all three parameters of efficacy, safety and tolerability versus all standard of care TKIs. This [asciminib] data has the potential to be practice changing.”

Read more: Jorge Cortes, MD, Shares Data on Asciminib Versus TKIs in CML

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