OnCo
drugsProductApproved2015🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Alectinib

Alectinib is a well-tolerated ALK pill, standard first line for years and, since 2024, the first targeted therapy given after surgery for ALK-positive lung cancer.

ALEX (2017): PFS 34.8 vs 10.9 months versus crizotinib with strong CNS control. ALINA (2024): adjuvant alectinib cut recurrence by 76% versus chemotherapy. Being challenged first line by lorlatinib (CROWN) and, in the ALKAZAR trial, by neladalkib.

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Alectinib
PubChem
Modality
Small-molecule kinase inhibitor (ALK)
Mechanism
ATP-competitive second-generation ALK inhibitor, CNS-penetrant, spares ROS1.
Brand / code
Alecensa
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. ALK rearrangement by an approved test.

Assistance programmes

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.

NICE recommendedNICE TA536 · 2018SMC: accepted
Appraised for
Untreated ALK-positive advanced NSCLC
Notes
Adjuvant ALK-positive NSCLC (ALINA) appraised 2024-25; check NICE.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA536 · SMC advice: alectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2015ALK+ NSCLC after crizotinib
US2017First-line ALK+ NSCLC
US2024Adjuvant ALK+ NSCLC after resection (stage IB ≥4 cm to IIIA)

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Alectinib
intervention: Alectinib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend181 papers in the last 12 months+6% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Alectinib" OR ABSTRACT:"Alectinib" OR TITLE:"Alecensa" OR ABSTRACT:"Alecensa") 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 Alectinib, not a curated reading list.

Connected

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