SCEMBLIX

What it is

SCEMBLIX is available in film-coated tablet strengths of 20 mg, 40 mg and 100 mg, each containing asciminib hydrochloride as the active ingredient. Asciminib is an oral and potent inhibitor of ABL/BCR::ABL1 tyrosine kinases. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein by specifically targeting the ABL myristoyl pocket. SCEMBLIX is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: — Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) — Ph+ CML in CP previously treated with two or more tyrosine kinase inhibitors — Ph+ CML in CP with the T315I mutation

Dosing overview

For Ph+ CML in chronic phase, the recommended total daily dose of SCEMBLIX is 80 mg, taken orally either as 80 mg once daily or as 40 mg twice daily at approximately 12-hour intervals. For Ph+ CML in chronic phase harbouring the T315I mutation, the recommended dose is 200 mg taken orally twice daily at approximately 12-hour intervals.

Key safety warnings

Myelosuppression including thrombocytopenia, neutropenia and anaemia occurred in patients receiving SCEMBLIX, with severe grade 3 or 4 thrombocytopenia and neutropenia reported during treatment. Myelosuppression was generally reversible and managed by temporarily withholding SCEMBLIX. Complete blood counts should be performed every two weeks for the first 3 months of treatment and monthly thereafter, or as clinically indicated. Clinical pancreatitis events occurred in 2% of patients receiving SCEMBLIX with grade 3 reactions in 1.1% of patients. Asymptomatic elevation of serum lipase and amylase occurred in 19.2% of patients, with grade 3 and 4 reactions in 7.4% and 2% of patients respectively. SCEMBLIX was permanently discontinued in 2% of patients due to symptomatic elevation of serum lipase and amylase. Serum lipase and amylase levels should be assessed monthly during treatment with SCEMBLIX, or as clinically indicated. Patients should be monitored for signs and symptoms of pancreatic toxicity. More frequent monitoring should be performed in patients with a history of pancreatitis. Electrocardiogram QT prolongation occurred in 0.9% of patients receiving SCEMBLIX. One patient had prolonged QTcF greater than 500 ms with more than 60 ms QTcF increase from baseline and one patient had prolonged QTcF with more than 60 ms QTcF increase from baseline. An electrocardiogram is recommended prior to the start of treatment with SCEMBLIX and monitored during treatment as clinically indicated. Hypokalaemia and hypomagnesaemia should be corrected prior to SCEMBLIX administration and monitored during treatment as clinically indicated. Hypertension occurred in 15.8% of patients receiving SCEMBLIX, with grade 3 and 4 reactions reported in 8.5% and 0.2% of patients respectively. Hypertension should be monitored and managed using standard antihypertensive therapy during treatment with SCEMBLIX as clinically indicated.

Contraindications

SCEMBLIX is contraindicated in patients with known hypersensitivity to the active substance asciminib or to any of the excipients.

PBS listing

SCEMBLIX 40 mg and 20 mg tablets are listed on the PBS with authority required and streamlined restrictions. The ex-manufacturer price is A$6012.50.

Regulatory history

SCEMBLIX 20 mg and 40 mg film-coated tablets were first listed on the ARTG on 15 July 2022. The TGA registration decision was made on 14 July 2022. The initial AusPAR approval covered patients with Ph+ CML in chronic phase previously treated with two or more tyrosine kinase inhibitors and those with the T315I mutation. PBAC initially did not recommend SCEMBLIX in July 2022, but recommended it in November 2022 for chronic myeloid leukaemia (Philadelphia chromosome-positive, previously treated with two or more tyrosine kinase inhibitors). The 100 mg film-coated tablet was added to the ARTG on 26 August 2025.