NDAORALTABLETPriority Review
Approved
Jul 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
GILOTRIF (afatinib) by Boehringer Ingelheim is protein kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2013.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GILOTRIF (afatinib) is an oral small-molecule protein kinase inhibitor approved in 2013 for the treatment of kinase-driven malignancies. It irreversibly binds and inhibits multiple kinase targets, blocking cancer cell proliferation and survival signaling. The drug is administered as an oral tablet and represents a foundational kinase inhibitor in Boehringer Ingelheim's oncology portfolio.
$51MPart D
Peak4.5 years to LOEProduct is at peak commercial maturity with moderate Medicare utilization; team focus is on maintaining market position in a crowded kinase inhibitor space.
Mechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Started Apr 2024
70 enrolled
Advanced Solid TumorUnresectable Solid TumorMetastatic Solid Tumor+1 more
Observational Study of Afatinib 30 mg Daily
Started Oct 2022
69 enrolled
Non-Small Cell Lung CancerEpidermal Growth Factor Receptor Mutation
Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma
Started Oct 2022
20 enrolled
Chordoma of Clivus
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
Started Oct 2021
25 enrolled
Squamous Cell Carcinoma
Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
Started Aug 2021
805 enrolled
Non-squamous, Non-Small Cell Lung Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.