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  1. pharmadog
  2. ›drugs
  3. ›Xalkori
drug · small molecule
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crizotinib

Marketedupdated 3mo ago
by $PFE PFIZER INC🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for neoplasm and non-small cell lung carcinoma and 14 investigational indications.

indications

investigational
NSCLC

targets

EML4-ALKNPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor)ALK tyrosine kinase receptorHepatocyte growth factor receptorMacrophage-stimulating protein receptor

all catalysts(0)

nothing on the calendar yet

Trials studying crizotinib

  • phase2National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancercompletedn=423
  • phase3A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patientsrecruitingn=194
  • —Safety and Efficacy of Xalkori ROS1active not recruitingn=97
  • phase4Crizotinib Continuation Clinical Studyactive not recruitingn=27
  • phase2Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)recruitingn=720
  • phase3A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)active not recruitingn=187
  • phase3A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastasesactive not recruitingn=220
  • phase3A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Canceractive not recruitingn=200
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
May 12, 2027
272 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (15)

  • Nov 6, 2029compositionUS 82170573.2y
  • Nov 6, 2029compositionUS 82170573.2y
  • Nov 6, 2029compositionUS 82170573.2y
  • Nov 6, 2029compositionUS 82170573.2y
  • Nov 6, 2029compositionUS 82170573.2y
  • Oct 8, 2029compositionUS 78586433.2y
  • Oct 8, 2029compositionUS 78586433.2y
  • Oct 8, 2029compositionUS 78586433.2y
  • Oct 8, 2029compositionUS 78586433.2y
  • Oct 8, 2029compositionUS 78586433.2y
  • May 12, 2027method-of-use (U-3057)US 7825137272d
  • May 12, 2027method-of-use (U-3058)US 7825137272d
  • May 12, 2027method-of-use (U-3057)US 7825137272d
  • May 12, 2027method-of-use (U-3403)US 7825137272d
  • May 12, 2027method-of-use (U-3058)US 7825137272d

FDA exclusivities (4)

  • Jul 14, 2029ODE-407Orphan Drug (7y)2.9y
  • Jul 14, 2029ODE-407Orphan Drug (7y)2.9y
  • Jan 14, 2028ODE-328Orphan Drug (7y)1.4y
  • Jan 14, 2028ODE-328Orphan Drug (7y)1.4y

News(5)

  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    biopharma_dive · 20d ago
  • GSK boosts cancer pipeline with $11B Nuvalent buyout
    The British drugmaker's third acquisition this year gives it two experimental lung cancer drugs under FDA review that it hopes will support a franchise.
    biopharma_dive · 2mo ago
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 3mo ago
  • OncLive Polls Reveal Picks for Top Lung Cancer Abstracts at ASCO 2026
    Lung cancer experts rank key abstracts of interest from the upcoming ASCO Annual Meeting on OncLive’s social media.
    onclive · 3mo ago
  • Track the Lung Cancer Abstracts That are Gaining Attention at ASCO 2026
    Read on to see what data are poised to shape clinical discussions and decision-making in lung cancer at 2026 ASCO Annual Meeting in Chicago, Illinois.
    onclive · 3mo ago
brand
Xalkori
trade names
Xalkori
generic
crizotinib
MOA
EML4-ALK inhibitor; NPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor; ALK tyrosine kinase receptor inhibitor; Hepatocyte growth factor receptor inhibitor; Macrophage-stimulating protein receptor inhibitor; Proto-oncogene tyrosine-protein kinase ROS inhibitor
indication
Anaplastic Large Cell Lymphoma (ALCL)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 6m ago
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