MedPath

Afatinib

Generic Name
Afatinib
Brand Names
Gilotrif, Giotrif
Drug Type
Small Molecule
Chemical Formula
C24H25ClFN5O3
CAS Number
850140-72-6
Unique Ingredient Identifier
41UD74L59M

Overview

Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif . For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim .

Background

Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif . For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim .

Indication

Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test , and (b) adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy . Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim's Gilotrif (afatinib) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I .

Associated Conditions

  • Metastatic Non-Small Cell Lung Cancer
  • Refractory, metastatic squamous cell Non-small cell lung cancer

FDA Approved Products

Gilotrif
Manufacturer:Boehringer Ingelheim Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2022/04/13
NDC:0597-0141
Gilotrif
Manufacturer:Boehringer Ingelheim Pharmaceuticals, Inc.
Route:ORAL
Strength:30 mg in 1 1
Approved: 2022/04/13
NDC:0597-0137
Gilotrif
Manufacturer:Boehringer Ingelheim Pharmaceuticals, Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2022/04/13
NDC:0597-0138

Singapore Approved Products

GIOTRIF FILM-COATED TABLETS 50MG
Manufacturer:Boehringer Ingelheim Pharma GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:50.0000mg
Online:Yes
Approved: 2013/12/17
Approval:SIN14463P
GIOTRIF FILM-COATED TABLETS 20MG
Manufacturer:Boehringer Ingelheim Pharma GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:20.0000mg
Online:Yes
Approved: 2013/12/17
Approval:SIN14460P
GIOTRIF FILM-COATED TABLETS 30MG
Manufacturer:Boehringer Ingelheim Pharma GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:30.0000mg
Online:Yes
Approved: 2013/12/17
Approval:SIN14461P
GIOTRIF FILM-COATED TABLETS 40MG
Manufacturer:Boehringer Ingelheim Pharma GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:40.0000mg
Online:Yes
Approved: 2013/12/17
Approval:SIN14462P

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