medwireNews: The US FDA has expanded the indication for afatinib to include patients with first-line non-small-cell lung cancer (NSCLC) and non-resistant epidermal growth factor receptor (EGFR) mutations.
Patients whose tumours test positive using an approved diagnostic test for the S7681, L861Q and/or G719X mutations may now be given the EGFR and HER2 targeted tyrosine kinase inhibitor at an oral daily dose of 40 mg.
Afatinib was initially approved by the FDA for metastatic NSCLC positive for an EGFR exon 19 deletion or an exon 21 substitution, and then later for patients with metastatic squamous NSCLC that has progressed after platinum-based chemotherapy.
The current expansion follows pooled results from the LUX-Lung 2, 3 and 6 clinical trials showing that patients with the non-resistant EGFR mutations had a confirmed objective response rate of 66% to afatinib, with a durable response of at least 12 months reported for half the group.
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