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Osimertinib tablet
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations, blocking downstream signaling in cancer cells.
Osimertinib is a third-generation EGFR tyrosine kinase inhibitor that irreversibly binds to and inhibits mutant EGFR, including T790M resistance mutations, blocking downstream signaling in cancer cells. Used for Metastatic non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line), Metastatic non-small cell lung cancer with EGFR T790M mutation (second-line, after progression on first/second-generation EGFR inhibitors).
At a glance
| Generic name | Osimertinib tablet |
|---|---|
| Also known as | placebo Tagrisso, bevacizumab |
| Sponsor | Shanghai JMT-Bio Inc. |
| Drug class | EGFR tyrosine kinase inhibitor (third-generation) |
| Target | EGFR (Epidermal Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Osimertinib selectively targets activating EGFR mutations (exon 19 deletions, L858R) and the T790M resistance mutation that emerges during first- or second-generation EGFR inhibitor therapy. By covalently binding to the ATP-binding pocket of mutant EGFR, it prevents autophosphorylation and downstream proliferation signals (MAPK/PI3K pathways), leading to cell cycle arrest and apoptosis in EGFR-mutant lung cancer cells.
Approved indications
- Metastatic non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations (first-line)
- Metastatic non-small cell lung cancer with EGFR T790M mutation (second-line, after progression on first/second-generation EGFR inhibitors)
Common side effects
- Diarrhea
- Rash
- Dry skin
- Nausea
- Fatigue
- Stomatitis
- Interstitial lung disease
Key clinical trials
- Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (PHASE3)
- A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations (PHASE2)
- Premedication to Reduce Amivantamab Associated Infusion Related Reactions (PHASE2)
- A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PHASE3)
- Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations (PHASE1)
- First in Human Study of AZD9592 in Solid Tumors (PHASE1)
- A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PHASE2)
- A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases (PHASE3)
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:
- Osimertinib tablet CI brief — competitive landscape report
- Osimertinib tablet updates RSS · CI watch RSS
- Shanghai JMT-Bio Inc. portfolio CI