The FDA has announced today that it approves Boehringer’s Gilotrif (afatinib) for the treatment of patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved Qiagen diagnostic test.
“Today’s approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments. Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations.”
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The decision follows the approval of Roche’s Tarceva (erlotinib) for first-line treatment of patients with NSCLC when used concurrently with a companion diagnostic test.
“The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them.”
Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
FDA approval for Boehringer means fast competition to Roche’s targeted Tarceva (FiercePharma)
FDA approves new treatment for a type of late-stage lung cancer (Press release)