FDA broadens Boehringer Ingelheim’s afatinib indication to previously untreated, metastatic NSCLC

Boehringer Ingelheim Pharmaceuticals has gotten an approval from the FDA, for a broadened indication of its afatinib for patients with metastatic non-small cell lung cancer, whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

As the American health authority said, the approval was based on demonstration of durable responses in a subset of 32 afatinib-treated patients with metastatic NSCLC harboring non-resistant EGFR mutations, other than exon 19 deletions or exon 21 L858R substitutions enrolled in one of three clinical trials, LUX-Lung 3, and LUX-Lung 6.

The FDA has explained that non-resistant EGFR mutations were identified using either Sanger sequencing or by the therascreen EGFR RGQ PCR Kit. EGFR mutations included in the non-resistant subgroup demonstrated inhibition of cellular proliferation in EGFR-mutant dependent cell lines at clinically relevant concentrations of afatinib. All patients in the subgroup received afatinib 40 mg or 50 mg orally once daily.

The FDA initially approved afatinib in 2013 for the treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test and in 2016 for metastatic, squamous NSCLC progressing after platinum-based chemotherapy.