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Asciminib is a BCR::ABL1 blocker that binds a different pocket from every other TKI, approved for all newly diagnosed chronic myeloid leukaemia in 2024 and now being tested in Ph-positive ALL.
Binds the myristoyl pocket (STAMP), so it works against ATP-site resistance mutations and combines with ATP-competitive TKIs. ASCEMBL (third line) and ASC4FIRST (frontline CML: MMR at 48 weeks 67.7% vs 49.0% for investigator-selected TKIs) led to approvals in 2021 and October 2024. Trials combine asciminib with dasatinib or ponatinib and with blinatumomab in Ph+ ALL to pre-empt resistance. Included here because Ph+ ALL shares the target.
Allosteric inhibitor locking ABL1 in an inactive conformation via the myristoyl pocket; active against T315I at higher dose. Connects to BCR::ABL1 (Philadelphia chromosome) and ABL1.
1.Asciminib occupies the myristoyl pocket, mimicking the natural auto-inhibitory switch
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. First-line CML label (2024) has loosened prior-TKI requirements at some plans.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA813 · SMC advice: asciminib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
Confirmed: the accelerated approval of 2021 converted to traditional approval 1.0 year after it was granted.
Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 1.9 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2021 | CML after ≥2 prior TKIs; T315I CML |
| US | 2024 | Newly diagnosed Ph+ CML in chronic phase (ASC4FIRST) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Thrombocytopenia | - | 17% |
| Hypertension | 13% | - |
| Pancreatic enzyme elevation | 13% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Asciminib" OR ABSTRACT:"Asciminib" OR TITLE:"Scemblix" OR ABSTRACT:"Scemblix") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Asciminib, not a curated reading list.
Shares A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP), A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares BCR::ABL1 T315I, ABL1, Ph-positive ALL, BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR).
Shares ABL1, A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), Ph-positive ALL.
Shares A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP, Sokal and ELTS risk scores (chronic myeloid leukaemia), BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR), BCR::ABL1 kinase domain mutations (T315I and others).
Shares Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia, Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib., Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia, Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP.
Shares IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia, Chronic myeloid leukaemia, chronic phase, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
Shares Ph-positive ALL, Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL), BCR::ABL1 (Philadelphia chromosome), Acute lymphoblastic leukaemia.