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The FDA granted accelerated approval to the for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase for patients previously treated with two or more tyrosine kinase inhibitors (TKIs), and also approved the drug in these patients with the T315I mutation.

These new indications were based on the ASCEMBL and CABL001X2101 trials, respectively.

"The introduction of TKIs twenty years ago revolutionized treatment for CML; however, there remain many patients who do not respond adequately to at least two available treatments and often experience challenging side effects that add a burden to their daily lives," said Lee Greenberger, PhD, chief scientific officer at the Leukemia & Lymphoma Society, in a . "The approval of Scemblix may offer hope to patients by addressing gaps in CML care."

was a multicenter, randomized, active-controlled, open-label clinical trial comparing asciminib with bosutinib (Bosulif) in patients with Philadelphia chromosome-positive CML in chronic phase who were previously treated with two or more TKIs.

This study randomized 233 patients 2:1 to receive either asciminib 40 mg twice daily or bosutinib 500 mg once daily. Patients were stratified according to major cytogenetic response status. The primary outcome was major molecular response (MMR) at 24 weeks. The MMR rate in the asciminib arm was 25% (95% CI 19-33) compared with 13% (95% CI 6.5-23) in the bosutinib group (P=0.029). At 20 months' follow-up, the median duration of MMR had not been reached.

The recommended dose of asciminib in these patients is 80 mg once daily or 40 mg twice daily.

was a multicenter, open-label clinical trial evaluating asciminib in patients with Philadelphia chromosome-positive CML in chronic phase with the T315I mutation. Forty-five patients received asciminib 200 mg twice daily (the recommended dose in this population) and continued treatment until unacceptable toxicity or treatment failure.

The primary outcome of MMR was achieved in 42% (95% CI 28-58) of patients at 24 weeks, and in 49% of patients (95% CI 34-64) at 96 weeks. The median duration of treatment was 108 weeks.

The most common adverse reactions (≥20%) with asciminib were upper respiratory tract infections, musculoskeletal pain, fatigue, nausea, rash, and diarrhea, while the most common laboratory abnormalities were decreased platelet counts, neutrophil counts, and hemoglobin, and increased triglycerides, creatine kinase, alanine aminotransferase, lipase, and amylase.

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