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PF-02341066
PF-02341066 is a ALK/ROS1 tyrosine kinase inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 3 development for ALK-positive non-small cell lung cancer, ROS1-positive non-small cell lung cancer. Also known as: cMET inhibitor, Crizotinib, crizotinib.
PF-02341066 is a tyrosine kinase inhibitor that targets ALK (anaplastic lymphoma kinase) and ROS1 to block aberrant signaling in cancer cells.
PF-02341066 is a medication studied in clinical trials for the treatment of Non Small Cell Lung Cancer, Lung Cancer, Adenocarcinoma, NSCLC, and Carcinoma. It is a C-MET inhibitor, as indicated by its use in combination with a PAN-HER inhibitor in a Phase 1 clinical trial.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | PF-02341066 |
|---|---|
| Also known as | cMET inhibitor, Crizotinib, crizotinib |
| Sponsor | Pfizer |
| Drug class | ALK/ROS1 tyrosine kinase inhibitor |
| Target | ALK, ROS1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The drug inhibits ALK and ROS1 receptor tyrosine kinases, which are frequently dysregulated in certain cancers through gene fusions or mutations. By blocking these kinases, PF-02341066 prevents downstream signaling that drives cancer cell proliferation and survival. This mechanism is particularly effective in ALK-positive and ROS1-positive non-small cell lung cancers.
Approved indications
- ALK-positive non-small cell lung cancer
- ROS1-positive non-small cell lung cancer
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Fatigue
- Edema
- Vision disorders
Key clinical trials
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (NA)
- Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) (PHASE2)
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
- Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) (PHASE2)
- A 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) (PHASE3)
- Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PF-02341066 CI brief — competitive landscape report
- PF-02341066 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about PF-02341066
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Related
- Drug class: All ALK/ROS1 tyrosine kinase inhibitor drugs
- Target: All drugs targeting ALK, ROS1
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for ALK-positive non-small cell lung cancer
- Indication: Drugs for ROS1-positive non-small cell lung cancer
- Also known as: cMET inhibitor, Crizotinib, crizotinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing