Therapeutic Response

BCR::ABL1 status confers therapeutic sensitivity to Asciminib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

Statements

Source and description
Scemblix (asciminib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Scemblix (asciminib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to asciminib for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). The package insert states that this indication is approved under accelerated approval based on major molecular response rate and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).
Scemblix (asciminib) [product information]. EMA. The European Medicines Agency (EMA) has authorized asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
Asciminib Monotherapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved asciminib for reimbursement as a monotherapy treatment option for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase, who have been previously treated with two or more tyrosine kinase inhibitors (TKIs). The therapy regimen further states that hypersensitivity to asciminib or to any of the excipients, presence of the T315I mutation, and pregnancy / breastfeeding are exclusion criteria.