MedPath

Dacomitinib

Generic Name
Dacomitinib
Brand Names
Vizimpro
Drug Type
Small Molecule
Chemical Formula
C24H25ClFN5O2
CAS Number
1110813-31-4
Unique Ingredient Identifier
2XJX250C20

Overview

Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains. Dacomitinib was developed by Pfizer Inc and approved by the FDA on September 27, 2018. Some evidence in the literature suggests the therapeutic potential of dacomitinib in the epithelial ovarian cancer model, although further investigations are needed.

Background

Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains. Dacomitinib was developed by Pfizer Inc and approved by the FDA on September 27, 2018. Some evidence in the literature suggests the therapeutic potential of dacomitinib in the epithelial ovarian cancer model, although further investigations are needed.

Indication

Dacomitinib is indicated as the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as verified by an FDA-approved test. Lung cancer is the leading cause of cancer death and NSCLC accounts for 85% of lung cancer cases. From the cases of NSCLC, approximately 75% of the patients present a late diagnosis with metastatic and advanced disease which produces a survival rate of 5%. The presence of a mutation in EGFR accounts for more than the 60% of the NSCLC cases and the overexpression of EGFR is associated with frequent lymph node metastasis and poor chemosensitivity.

Associated Conditions

  • Metastatic Non-Small Cell Lung Cancer

FDA Approved Products

Vizimpro
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:15 mg in 1 1
Approved: 2020/12/01
NDC:0069-0197
Vizimpro
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:15 mg in 1 1
Approved: 2020/12/23
NDC:63539-197
Vizimpro
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:30 mg in 1 1
Approved: 2020/12/01
NDC:0069-1198
Vizimpro
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:45 mg in 1 1
Approved: 2020/12/01
NDC:0069-2299

Singapore Approved Products

VIZIMPRO FILM-COATED TABLET 45MG
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:45 mg
Online:Yes
Approved: 2020/06/25
Approval:SIN15965P
VIZIMPRO FILM-COATED TABLET 30MG
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:30 mg
Online:Yes
Approved: 2020/06/25
Approval:SIN15967P
VIZIMPRO FILM-COATED TABLET 15MG
Manufacturer:Pfizer Manufacturing Deutschland GmbH
Form:TABLET, FILM COATED
Strength:15 mg
Online:Yes
Approved: 2020/06/25
Approval:SIN15966P

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