Gilotrif (afatinib) approved for patients with metastatic non–small cell lung cancer (NSCLC)
Last week the FDA approved Gilotrif (afatinib), a tyrosine kinase inhibitor, for patients with metastatic NSCLC tumors expressing the epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. At the same time, a companion test, the therascreen EGFR RGQ PCR Kit, was also approved by the FDA and is used to determine whether a patient’s tumor expresses these EGFR gene mutations.
Source: FDA News Release.