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BCR-ABL1 STAMP Inhibitor (ABL Myristoyl Pocket Binder) Pregnancy: Contraindicated — embryotoxic; effective contraception during and for 1 week after treatment

Asciminib

Brand names: Scemblix

Adult dose

Dose: Non-T315I: 40 mg twice daily; T315I mutation: 200 mg twice daily
Route: Oral
Frequency: Twice daily
Max: 400 mg/day (T315I regimen)
CML chronic phase ≥2 prior TKIs; take on empty stomach (no food ±2 hours); T315I regimen has higher dose; molecular response monitoring essential

Paediatric dose

Dose: Not established N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed in paediatrics

Dose adjustments

Renal

No dose adjustment for mild-moderate renal impairment; limited data in severe

Hepatic

Mild: no adjustment; moderate: consider dose reduction; severe: avoid

Paediatric weight-based calculator

Not licensed in paediatrics

Clinical pearls

  • ASCEMBL trial (Réa et al. NEJM 2021): asciminib achieved superior MMR at 24 weeks vs bosutinib in heavily pre-treated CML (25.5% vs 13.2%) with fewer discontinuations due to adverse events
  • STAMP (Specifically Targeting the ABL Myristoyl Pocket) is a novel mechanism — allosteric binding distinct from ATP-competitive TKIs; retains activity against T315I 'gatekeeper' mutation at higher dose
  • MHRA 2022 approved; NICE TA805 for CML ≥2 prior TKIs; represents a third mechanism in CML after ATP-competitive first/second-generation and ponatinib (which also covers T315I)
  • Cardiovascular monitoring important — arterial occlusive events (MI, stroke, peripheral arterial disease) reported; baseline cardiovascular risk assessment required
  • Pancreatitis: monitor amylase/lipase — hold asciminib if ≥3× ULN asymptomatic or any symptomatic elevation; resume at reduced dose after resolution

Contraindications

  • Known hypersensitivity
  • Active hepatitis B/C without treatment

Side effects

  • Thrombocytopenia
  • Neutropenia
  • Hypertension
  • Pancreatitis
  • Cardiovascular events (arterial occlusion)
  • Fatigue
  • Arthralgia
  • Rash

Interactions

  • CYP3A4 substrates — asciminib inhibits CYP3A4; monitor narrow therapeutic index drugs (e.g. ciclosporin, tacrolimus)
  • Strong CYP3A4 inhibitors — increase asciminib exposure
  • Antacids/PPIs — no interaction (not pH-dependent absorption, unlike other TKIs)

Monitoring

  • BCR-ABL1 PCR (IS) every 3 months
  • FBC (monthly ×3, then every 3 months)
  • Amylase/lipase (monthly ×3)
  • Blood pressure
  • Cardiovascular risk factors
  • LFTs

Reference: BNFc; BNF 90; ASCEMBL trial (Réa et al. NEJM 2021); NICE TA805; MHRA SPC Scemblix; CABL001B2201 T315I study (Hughes et al. NEJM 2019). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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