What Is Dacomitinib (Vizimpro)? FDA Approval, Licensing in Türkiye, and Reimbursement Status
Reading tools
In this article
Second-Generation Blockade in NSCLC Treatment: Dacomitinib
Used to treat metastatic non-small cell lung cancer (NSCLC), Dacomitinib (Vizimpro®) is a targeted agent with a proven survival benefit that permanently stops receptor signaling in patients with EGFR mutations.
Drug Profile
- Brand Name: Vizimpro®
- Active Ingredient: Dacomitinib
- Class: Second-Generation, Irreversible Tyrosine Kinase Inhibitor (TKI)
- Route of Administration: Oral (Tablet)
- Manufacturer: Pfizer
🇹🇷 Status in Türkiye (License, Price, and SGK):
- License: Licensed in Türkiye.
- Payment: Included on the SGK reimbursement list.
- Reimbursement Conditions: Indicated for use until progression in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring an EGFR exon 19 deletion or exon 21 L858R mutation.
- March 2026 Price: The price of 1 box containing 30 tablets of 15/30/45 mg is 58,420.15 TL.
Approved Indications
- Metastatic NSCLC (First Line): Used as initial therapy in patients with an identified EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.
FDA Approval History
📅 September 27, 2018: First-Line Approval
The FDA approved Vizimpro based on the results of the ARCHER 1050 study because it significantly prolonged progression-free survival (PFS) and overall survival (OS) compared with gefitinib, a first-generation TKI, in patients with EGFR-mutated NSCLC.
What Is Dacomitinib, and What Is Its Molecular Mechanism of Action?
Dacomitinib is a molecule that selectively and permanently blocks signaling by ErbB-family receptor tyrosine kinases (EGFR/ErbB1, HER2/ErbB2, and HER4/ErbB4).
🔬 How It Works at the Molecular Level
- 1. Covalent Binding:
Dacomitinib binds irreversibly to the ATP-binding site. Unlike first-generation drugs (Erlotinib, Gefitinib), this completely prevents the receptor from becoming active again. - 2. Broad-Spectrum ErbB Blockade:
By suppressing not only EGFR but the entire ErbB family, it makes it harder for the tumor to diversify its signaling pathways (find escape routes). - 3. Cell-Cycle Arrest:
When signaling is interrupted, the cell cycle stops in the G1 phase and the cancer cell undergoes apoptosis (programmed cell death).
Administration and Dosage
Dacomitinib should be taken as an oral tablet every day at the same time.
- Standard Dose: 45 mg, 1 time daily.
- Relation to Food: May be taken with food or on an empty stomach.
- Dose Modification: Depending on the severity of side effects, the dose may be reduced gradually to 30 mg and, if necessary, to 15 mg.
Side Effects and Management
The side effects seen with Vizimpro reflect the drug's potent activity against EGFR:
- Diarrhea: The most common side effect (87%). Loperamide should be prescribed at the start of treatment.
- Dermatological Effects: Acneiform rash (70%+), dry skin, and inflammation around the nails (paronychia). Moisturizers and, if needed, topical antibiotics are recommended.
- Stomatitis: Mouth sores and mucosal irritation (45%).
- Loss of Appetite and Weight Loss: Requires regular nutritional monitoring.
- Interstitial Lung Disease (ILD): A rare but life-threatening side effect. If a new cough or shortness of breath develops, the drug should be discontinued and an assessment performed.
Special Situations and Warnings
- Drug Interactions (Acid-Suppressing Agents): Proton pump inhibitors (PPIs, such as Omeprazole) reduce the absorption of Vizimpro. PPI use should be avoided; if needed, locally acting antacids or H2 receptor antagonists (famotidine) should be used 6-10 hours after taking the drug.
- Liver Function: Periodic liver enzyme tests (AST, ALT) should be performed during treatment.
- Pregnancy: May harm the fetus. Effective contraception should be used during treatment and for at least 17 days after the last dose.
- Breastfeeding: Breastfeeding is not recommended during treatment or for at least 17 days after the last dose.
Pharmacokinetic Summary
- Half-Life: Approximately 70 hours (elimination from the body is prolonged).
- Metabolism: Metabolized in the liver through CYP2D6 (the main pathway) and CYP3A4.
- Elimination: Largely eliminated from the body through feces.
Was this article helpful?
Your feedback helps us improve our content.
Reader comments
Share your comment
Your name and comment are published only after administrator approval. Your email address is never shown to visitors.
Be the first to comment.