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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

XALKORI

CRIZOTINIB Cytochrome P450 3A Inhibitors
Oncology Approved 2011-08-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
9
Indications
--
Phase 3 Trials
4
Priority Reviews
14
Years on Market

Details

Status
Prescription
First Approved
2011-08-26
Routes
ORAL
Dosage Forms
CAPSULE, PELLETS, CAPSULE

Companies

PF PRISM CV
Active Ingredient: CRIZOTINIB

XALKORI Approval History

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What XALKORI Treats

3 indications

XALKORI is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Small Cell Lung Cancer
  • Anaplastic Large Cell Lymphoma
  • Inflammatory Myofibroblastic Tumor
Source: FDA Label

XALKORI Target & Pathway

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Target

ALK (Anaplastic Lymphoma Kinase) Receptor Tyrosine Kinase

A receptor tyrosine kinase that, when mutated or rearranged, drives cancer cell growth. ALK rearrangements occur in about 5% of non-small cell lung cancers. Inhibiting ALK blocks aberrant signaling that promotes tumor survival and proliferation.

XALKORI Competitors

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6 other drugs also target ALK. Compare mechanisms, indications, and trial activity.

ROZLYTREK
Roche
ALUNBRIG
Takeda
ZYKADIA
Novartis
ALECENSA
Roche
LORBRENA
Pfizer
ENSACOVE
XCOVERY
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (ALK). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to XALKORI

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALECENSA
ALECTINIB HYDROCHLORIDE
1 shared
Roche
Shared indications:
Non-Small Cell Lung Cancer
ALIMTA
PEMETREXED
1 shared
Eli Lilly
Shared indications:
Non-Small Cell Lung Cancer
ALUNBRIG
BRIGATINIB
1 shared
Takeda
Shared indications:
Non-Small Cell Lung Cancer
ALYMSYS
BEVACIZUMAB-MALY
1 shared
AMNEAL PHARMS LLC
Shared indications:
Non-Small Cell Lung Cancer
AUGTYRO
REPOTRECTINIB
1 shared
Bristol-Myers Squibb
Shared indications:
Non-Small Cell Lung Cancer
AVGEMSI
GEMCITABINE HYDROCHLORIDE
1 shared
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung Cancer
AVZIVI
BEVACIZUMAB-TNJN
1 shared
BIO-THERA SOLUTIONS LTD
Shared indications:
Non-Small Cell Lung Cancer
AXTLE
PEMETREXED DIPOTASSIUM
1 shared
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung Cancer
BEIZRAY
DOCETAXEL
1 shared
ZHUHAI
Shared indications:
Non-Small Cell Lung Cancer
BIZENGRI
ZENOCUTUZUMAB-ZBCO
1 shared
MERUS N.V.
Shared indications:
Non-Small Cell Lung Cancer
CYRAMZA
RAMUCIRUMAB
1 shared
Eli Lilly
Shared indications:
Non-Small Cell Lung Cancer
DATROWAY
DATOPOTAMAB DERUXTECAN-DLNK
1 shared
DAIICHI SANKYO INC
Shared indications:
Non-Small Cell Lung Cancer
DOCIVYX
DOCETAXEL
1 shared
AVYXA HOLDINGS
Shared indications:
Non-Small Cell Lung Cancer
EMRELIS
TELISOTUZUMAB VEDOTIN-TLLV
1 shared
AbbVie
Shared indications:
Non-Small Cell Lung Cancer
ENSACOVE
ENSARTINIB HYDROCHLORIDE
1 shared
XCOVERY
Shared indications:
Non-Small Cell Lung Cancer
ERLOTINIB HYDROCHLORIDE
ERLOTINIB HYDROCHLORIDE
1 shared
MSN
Shared indications:
Non-Small Cell Lung Cancer
GEFITINIB
GEFITINIB
1 shared
Cipla
Shared indications:
Non-Small Cell Lung Cancer
GILOTRIF
AFATINIB DIMALEATE
1 shared
Boehringer Ingelheim
Shared indications:
Non-Small Cell Lung Cancer
HERNEXEOS
ZONGERTINIB
1 shared
Boehringer Ingelheim
Shared indications:
Non-Small Cell Lung Cancer
HYRNUO
SEVABERTINIB
1 shared
Bayer
Shared indications:
Non-Small Cell Lung Cancer
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

XALKORI FDA Label Details

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Indications & Usage

FDA Label (PDF)

XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and ol...

XALKORI Patents & Exclusivity

Latest Patent: Nov 2029
Exclusivity: Jul 2029

Patents (65 active)

US8217057 Expires Nov 6, 2029
US7858643 Expires Oct 8, 2029
US7825137 Expires May 12, 2027
+ 55 more patents

Exclusivity

ODE-328 Until Jan 2028
ODE-407 Until Jul 2029
ODE-328 Until Jan 2028
ODE-407 Until Jul 2029
ODE-328 Until Jan 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA217581 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.