Efficacy and Safety Results of the Afatinib Expanded Access Program.

ABSTRACT:

Introduction

Afatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy.

Methods

The afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug.

Results

Three hundred twenty-two patients receiv

SUBMITTER: Kim ES 

PROVIDER: S-EPMC5488108 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature