Broome Oncology

FDA Broadens Gilotrif Indication to Previously Untreated, Metastatic NSCLC with Other Non-Resistant EGFR Mutations

CancerConnect News: The Food and Drug Administration (FDA) has granted approval to Gilotrif®  (afatinib) for a broadened indication in 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.

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. One sub-type of NSCLC is a type of lung cancer that is driven by a mutation in the epidermal growth factor receptor (EGFR) pathway. Each year in the United States over 18,000 individuals are diagnosed with NSCLC that harbors EGFR mutations. This type of cancer is associated with non-smokers and individuals of Asian descent.

EGFR is a protein located on the surface of many cancer cells that is involved in cancer growth. By blocking the EGFR pathway, targeted therapies help inhibit cancer growth. Gilotrif®  is a precision cancer medicine that blocks the EGFR pathway as well as the ErbB family of receptors that are associated with the EGFR pathway, including HER2 (ErbB2) and HER4 (ErbB4). Gilotrif® appears to block the EGFR pathway more thoroughly than other targeted therapies.

The current expanded FDA approval was based on demonstration of durable responses in a subset of 32 Gilotrif-treated patients with metastatic NSCLC harboring non-resistant EGFR mutations.  The confirmed overall response rate in this group was 66%.  Among the 21 responders, the proportion of patients with response duration of ≥12 months was 52% and the proportion with response durations of ≥18 months was 33%.


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