OnCo
drugsProductNot mapped hereapproved

Crizotinib

Crizotinib was the first ALK inhibitor, approved four years after ALK fusions were found in lung cancer; it was also the first drug for ROS1 lung cancer and for ALK-positive lymphoma and inflammatory myofibroblastic tumour in children.

PROFILE 1007/1014 established it over chemotherapy in ALK+ NSCLC (2011 accelerated, 2013 full); ROS1 approval 2016 (PROFILE 1001, 72% response). Superseded first line by alectinib, brigatinib and lorlatinib (poor CNS penetration). Paediatric approvals for ALK+ ALCL (2021) and IMT (2022). Visual disturbance, oedema, hepatotoxicity.

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Crizotinib
PubChem
Modality
Small-molecule ALK/ROS1/MET TKI (first generation)
Mechanism
ATP-competitive inhibitor of ALK, ROS1 and MET kinases.
Brand / code
Xalkori
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.

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 TA406 · 2016SMC: accepted
Appraised for
Untreated ALK-positive advanced NSCLC
Notes
ROS1-positive NSCLC: TA529 (2018).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA406 · SMC advice: crizotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2011ALK-positive metastatic NSCLC
US2016ROS1-positive metastatic NSCLC
US2021Relapsed ALK-positive ALCL in patients 1-21 years
US2022ALK-positive inflammatory myofibroblastic tumour

Trials

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Recruiting now (live from ClinicalTrials.gov)

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

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

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

Connected

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