Boehringer’s Afatinib Buoyed By Priority Review In Bid For Role In EGFR-Positive Lung Cancer
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA accepts the NDA for afatinib – among Boehringer’s first cancer drugs – for review in first-line EGFR-mutation positive non-small cell lung cancer. Filing is supported by LUX-Lung 3 study, in which the drug showed a 4.2 month progression-free survival benefit over what some describe as the most effective chemo doublet available.