FDA Expands Afatinib Indication in First-Line Treatment of Metastatic Lung Cancer
Posted: Tuesday, January 16, 2018
On January 12, 2018, the U.S Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) to expand the drug’s indication in the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant EGFR mutations, as detected by an FDA-approved test.
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.
Approval of the broadened indication 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 1 of 3 clinical trials (LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6). The confirmed overall response rate, as assessed by independent radiology review, was 66%. Among the 21 responders, the proportion of patients with a response duration of at least 12 months was 52%, and the proportion with a response duration of at least 18 months was 33%.
The most common adverse reactions reported for afatinib (at least 20%) across clinical trials were diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus.
