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FDA broadens afatinib indication

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Jan. 19, 2018Boehringer Ingelheim announced Tuesday the FDA has approved a supplemental new drug application for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung whose tumors have nonresistant epidermal growth factor receptor mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I. The FDA granted priority review status to Gilotrif in evaluating this application.

Approval was based on demonstration of durable responses in a subset of 32 afatinib-treated patients with metastatic NSCLC harboring nonresistant EGFR mutations (S768I, L861Q, and/or G719X) other than exon 19 deletions or exon 21 L858R substitutions enrolled in one of three clinical trials, LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6.

Nonresistant EGFR mutations were identified using either Sanger sequencing or by the Therascreen EGFR RGQ PCR Kit. EGFR mutations included in the nonresistant 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.

“Compared with other EGFR mutations, L861Q, G719X, or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” Edward Kim, MD, Levine Cancer Institute, Carolinas HealthCare System, said in a statement released by the company. “The approval of Gilotrif as a targeted therapy for these additional nonresistant EGFR mutations significantly alters the treatment strategy for this population.”

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.

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