Afatinib – LuciAfa

What it treats:

Afatinib, sold under the brand name Gilotrif (U.S.) or Giotrif (other markets), is an oral, second-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It is primarily used for the treatment of non-small cell lung cancer (NSCLC) in patients with specific EGFR mutations.

Metastatic Non-Small Cell Lung Cancer (NSCLC)

First-Line Treatment: For adults with metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations, as confirmed by an FDA-approved test (e.g., therascreen EGFR RGQ PCR Kit). It delays disease progression and improves progression-free survival (PFS).

Uncommon EGFR Mutations: For NSCLC with non-resistant EGFR mutations (e.g., G719X, S768I, L861Q) in the first-line setting.

Second-Line Treatment: For metastatic NSCLC with non-resistant EGFR mutations after progression on first-line EGFR TKIs (e.g., in T790M-negative cases).

Squamous NSCLC

For adults with locally advanced or metastatic squamous NSCLC who have progressed on platinum-based chemotherapy, based on the LUX-Lung 8 trial showing modest PFS and overall survival (OS) benefits over erlotinib.