Asciminib
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.
1.Asciminib occupies the myristoyl pocket, mimicking the natural auto-inhibitory switch
- Route
- Oral
- Schedule
- CML: 80 mg once daily or 40 mg twice daily; 200 mg twice daily for T315I
- Monitoring
- Pancreatic enzymes, blood pressure, myelosuppression
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Novartis Patient Support (Patient Assistance NOW Oncology)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Chronic phase CML after 2 or more TKIs
- Notes
- Untreated CML (ASC4FIRST) appraised 2025-26.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA813 · SMC advice: asciminib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- Approved indications are in chronic myeloid leukaemia; Ph+ ALL use is investigational.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductDasatinib
Shares Molecular response (MMR, MR4, treatment-free remission), Ph-positive ALL, Philadelphia chromosome (Ph+, BCR::ABL1), IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia.
- ProductPonatinib
Shares On-target resistance mutations (gatekeeper, solvent-front, compound), Ph-positive ALL, Philadelphia chromosome (Ph+, BCR::ABL1), BCR::ABL1 (Philadelphia chromosome).
- ProductNilotinib
Shares Molecular response (MMR, MR4, treatment-free remission), IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML).
- Key paperFirst imatinib trial: a pill that switched off the enzyme driving chronic myeloid leukaemia
Shares IRIS: imatinib versus interferon plus cytarabine as first treatment for chronic myeloid leukaemia, BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML), Novartis.
- ProductBosutinib
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML), Small-molecule kinase inhibitors.
- InstitutionOHSU Knight Cancer Institute
Shares BCR::ABL1 (Philadelphia chromosome), Chronic myeloid leukaemia (CML), Novartis, Small-molecule kinase inhibitors.
- TrialPhALLCON
Shares Ph-positive ALL, BCR::ABL1 (Philadelphia chromosome), Acute lymphoblastic leukaemia.
- TermTyrosine kinase inhibitor (TKI)
Shares Molecular response (MMR, MR4, treatment-free remission), On-target resistance mutations (gatekeeper, solvent-front, compound), Philadelphia chromosome (Ph+, BCR::ABL1), Small-molecule kinase inhibitors.