What is the role of afatinib (Gilotrif) in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Afatinib (Gilotrif) is a TKI that was approved by the FDA in July 2013 for first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by the diagnostic companion test therascreen EGFR RGQ PCR kit. Approval was based on data from the LUX-Lung 3 trial, in which progression-free survival in patients receiving afatinib was 11.1 months, compared with 6.9 months for those treated with pemetrexed/cisplatin. [147] In 2018, the indication for first-line use in metastatic NSCLC was expanded to include 3 additional nonresistant EGFR mutations (ie, L861Q, G719X, S768I). [148]

Additionally, in patients with tumors expressing the two most common EGFR mutations (Del19 or L858R), progression-free survival was 13.6 months in those who received afatinib, versus 6.9 months for those in the chemotherapy arm. [147]

In April 2016, the FDA approved afatinib for metastatic squamous NSCLC that has progressed after platinum-based chemotherapy. Approval was based on the LUX-Lung 8 clinical trial. Compared with erlotinib, afatinib obtained a significant delay in progression of lung cancer, reducing the risk of cancer progression by 18%. Also observed was a significant improvement in overall survival (p=0.0077), reducing the risk of death by 19%. A significantly improved disease control rate was also shown (51% vs 40%; P=0.002). [149]

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