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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.
Alectinib is an ATP-competitive second-generation ALK inhibitor that penetrates the central nervous system and spares ROS1. It is the long-standing first-line standard for ALK-positive non-small-cell lung cancer and, since 2024, the first targeted therapy given after surgery for resected ALK-positive disease. ALEX (2017) showed PFS of 34.8 versus 10.9 months against crizotinib with strong CNS control, and ALINA (2024) showed adjuvant alectinib cut recurrence by 76% versus chemotherapy (DFS HR 0.24 in stage II to IIIA). Its first-line position is being challenged by lorlatinib (CROWN) and, in the ALKAZAR trial, by neladalkib, so the open question is which ALK inhibitor to use first. For a newcomer, alectinib is the well-tolerated ALK pill that most patients start on and that now also protects against relapse after an operation.
ATP-competitive second-generation ALK inhibitor, CNS-penetrant, spares ROS1. Connects to ALK.
1.Alectinib slips into a pocket on ALK.
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. ALK rearrangement by an approved test.
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 TA536 · SMC advice: alectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib
Confirmed: the accelerated approval of 2015 converted to traditional approval 1.9 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | ALK+ NSCLC after crizotinib |
| US | 2017 | First-line ALK+ NSCLC |
| US | 2024 | Adjuvant ALK+ NSCLC after resection (stage IB ≥4 cm to IIIA) |
| England (NICE) | 2018 | Untreated ALK-positive advanced non-small-cell lung cancer · TA536, published 8 August 2018, within its marketing authorisation subject to the commercial arrangement (ALEX). |
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Adjuvant treatment for lung cancer is now chosen by genotype. A resected ALK-positive tumour is treated with two years of a tablet instead of four cycles of platinum, which is a different life as well as a different outcome.
First-line ALK treatment moved to a drug designed for the brain, and brain metastasis prevention became an explicit design goal rather than a hoped-for side effect. ALK-positive lung cancer is now among the longest-surviving metastatic solid tumours.
ALK is the reason young, KRAS wild-type patients should have fusion testing even though the overall rate is one in six hundred.
It made repeat biopsy and genotyping at progression the standard in ALK-positive lung cancer, because after a second-generation inhibitor the presence or absence of an ALK mutation is what separates patients who should receive a third-generation inhibitor from those who should not.
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.
Shares Identification of targetable ALK rearrangements in pancreatic ductal adenocarcinoma, ALESIA, J-ALEX, Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer.
Shares Neladalkib, Prevention trials aimed only at brain metastasis, Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK fusion (ALK-positive).
Shares A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small C, A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC), Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study, DETERMINE.
Shares Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK fusion (ALK-positive), Lung cancer drugs in England: what NICE has recommended, Inflammatory myofibroblastic tumour (IMT).
Shares Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK fusion (ALK-positive), Lung cancer drugs in England: what NICE has recommended, Non-small cell lung cancer (KEGG map).
Shares ALK fusion (ALK-positive), Non-small cell lung cancer (KEGG map), ALK-positive non-small-cell lung cancer, ALK.
Shares Neladalkib, ALK-positive non-small-cell lung cancer, ALK, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.
Shares Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC, Neladalkib, ALK-positive non-small-cell lung cancer, Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall.